The FDA issued An immediate recall for Sandimmune Oral Solution (Cyclosporine Oral Solution, USP) 100mg/mL. The drug, manufactured by Novartis Pharmaceuticals, has been noted to form crystals, resulting in incorrect dosing when taken orally. This could result in rejecting the transplanted organ or overdosing on Cyclosporine. As of the writing of this notice, no adverse events have yet been reported.

SUMMARY

Date of Recall:

Announced: September 11, 2023

Public Notification: September 11, 2023

Name(s) of Drug:

Sandimmune Oral Solution, 100 mg/mL

Cyclosporine Oral Solution, USP, 100 mg/ml

Company Name:

Novartis Pharmaceuticals Corporation

Drug Indication:

Organ Rejection

Rheumatoid Arthritis

Psoriasis

Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig Disease)

Product Description

Sandimmune oral is distributed in 50 mL bottles packaged in white boxes with blue trim. Each is clearly labeled with the drug name, strength, and lot information. The drug was distributed by pharmacies nationwide starting in April of 2023.

Reason for Recall

Crystallization of the drug within the solution will lead to non-uniform distribution of the drug within the solution. Thus, consumers taking the medication will ingest more or less of the drug than is ordered with each dose.

Impacts

Consumers who ingest the crystals will receive more of the drug than intended. This can lead to Cyclosporine toxicity. Symptoms include:

• Vomiting
• Tiredness
• Tachycardia (rapid heart rate)
• Jaundice (yellowing of skin and whites of eyes)
• Liver Damage
• Kidney Damage
• Swelling

Consumers who consume the solution after crystals have settled will receive a lower dose of the medication than indicated. This can lead to:

• Rejection of a transplanted organ
• Return of symptoms of psoriasis, rheumatoid arthritis, or ALS

Lot Information

Consumers who use Sandimmune Oral Solution, 100 mg/mL, should locate their medication and compare the lot number and expiration date to those below. See below for further instructions if your lot number and expiration date match.

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

1. If you believe you have ingested too high of a dose of the medication, call 911 immediately.
2. Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any changes in your symptoms.
3. Continue to monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
4. Consumers who experience an adverse event should contact Novartis Consumer Interaction Center at 1-888-NOW-NOVA. They are available Mon-Fri from 8:30 a.m. to 5:00 p.m. (EST). You can also contact them via email at medinfo@ibsapharma.com.
5. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
6. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Novartis at 1-888-669-6682, or you can utilize usdrugsafety.operations@novartis.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
3. Notify affected consumers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Novartis at 1-888-669-6682, or you can utilize usdrugsafety.operations@novartis.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
3. Notify affected retailers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal to the healthcare industry and the general public alike. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to help!

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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!

The FDA and Merck have recalled Banamine and Banamine-S, drugs used to treat dairy and beef cattle with fevers. Routine testing found that particulate matter is present in the formula, though Merck has not released information on what the matter consists of or why it has occurred. As of the date of this notice, no adverse events have yet been reported as a result of the contaminated injections.

SUMMARY

Date of Recall:

Announced: September 1, 2023

Public Notification: September 1, 2023

Name(s) of Drug:

Banamine

Banamine-S

Company Name:

Merck Animal Health

Drug Indication:

Fever in Dairy and Beef Cattle

Product Description

The injectable solution is distributed in clear glass bottles. Each has a gray label affixed with an orange block containing dosage information. Banamine was distributed by animal supply stores and pet pharmacies nationwide.

Reason for Recall

Merck performs routine testing of their products throughout the manufacturing process. During one of these tests, particulate matter was present in the recalled lots.

Impacts

Farmers and pet owners who inject the contaminated solution may note increased swelling, redness, irritation, or infection at the injection site. IV (intravenous) administration of the solution may lead to lung damage as the particulate matter travels throughout the animal’s bloodstream.

Lot Information

Cow owners with bottles of Banamine in their possession should immediately compare the identifying data on the bottle to that listed on the chart below. Additional steps will be required if a bottle matches one of the recalled lots.

FDA.gov

Have you found that your cow’s medication has been recalled? Here’s what you should do:

Consumers

1. Do not use the recalled medication. Seek out a replacement vial.
2. Monitor your cows for any adverse symptoms and notify your veterinarian if any concerns are noted.
3. Consumers with questions may call 1-800-521-5767 Mon-Fri from 8:00 am to 5:00 pm (CDT).
4. If your cows are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your veterinarian immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

1. Examine all inventory and remove stock affected by the recall immediately.
2. Call 1-800-521-5767. Notify the manufacturer of any recalled batches that have already been sold to consumers.
3. Notify affected consumers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

1. Examine all inventory and remove stock affected by the recall immediately.
2. Call 1-800-521-5767. Notify the manufacturer of recalled batches that have already been shipped to retailers.
3. Notify affected retailers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal to the healthcare industry and the general public alike. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to help!

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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!

The FDA has announced a recall of Digoxin Tablets USP due to mislabeling that could cause patients to ingest the incorrect dosage of the popular heart drug. Some Digoxin Tablets USP 0.25mg bottles are mislabeled as Digoxin Tablets USP, 0.125mg, causing patients to take double their prescribed dosage unknowingly. Meanwhile, some bottles of Digoxin Tablets USP. 0.125mg are mislabeled as Digoxin Tablets USP, 0.25mg, causing patients to receive only half of their prescribed dosage.

SUMMARY

Date of Recall:

Announced: August 30, 2023

Public Notification: August 31, 2023

Name(s) of Drug:

Digoxin Tablets USP, 0.125mg

Digoxin Tablets USP, 0.25mg

Company Name:

Marlex Pharmaceuticals, Inc.

Drug Indication:

Heart Failure

Pediatric Heart Failure

Atrial Fibrillation

Product Description

The pills are distributed in white plastic bottles labeled with the drug name, dosage, lot number, NDC number, and expiration date. Labels are blue and white and bear the manufacturer’s name, Marlex, accented in red. The recalled medications were distributed by pharmacies nationwide.

Reason for Recall

At the time of writing this notice, the FDA has not released any information related to adverse events related to the mix-up. However, accidental mislabeling of the bottles may cause consumers to unknowingly take the incorrect dose of their medication. This act can lead to serious consequences, including death.

Impacts

Consumers who ingest the mislabeled medication will either receive a potentially dangerous dose of the medication or will receive less than is necessary to manage their heart dysfunction.

Customers who ingest too much of the medication may experience symptoms such as:

• Dizziness
• Blurred Vision
• Confusion
• Memory Loss
• Nausea
• Vomiting
• Loss of Appetite
• Tiredness
• Loss of Consciousness

Customers who ingest only half of their prescribed dose may experience a return of their heart symptoms, leading to symptoms such as:

• Tiredness
• Weakness
• Shortness of Breath
• Irregular Heartbeat
• Swelling
• Dizziness
• Chest Pain

If you believe that you have ingested the incorrect dosage of this medication, seek medical attention immediately.

Recall Lot Information

All consumers who use Digoxin should locate their medication bottle and compare their label with the chart below. If the Product Description, NDC number, Lot number, and Expiration Date match those below, you must take additional steps to ensure your health and safety.

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

1. Seek medical attention immediately if you believe you have taken an incorrect dosage of your medication.
2. Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any changes in your health.
3. Monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
4. Consumers may contact Marlex Pharmaceuticals, Inc. at 1 (302) 328-3355. They are available Mon-Fri from 8:30 a.m. to 4:30 p.m. (EST).
5. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
6. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Marlex Pharmaceuticals, Inc. at 1 (302) 328-3355. Notify them of any recalled batches that have already been distributed to consumers.
3. Notify affected consumers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Marlex Pharmaceuticals, Inc. at 1 (302) 328-3355. Notify them of any recalled batches that have already been shipped to retailers.
3. Notify affected retailers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal to the healthcare industry and the general public alike. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to help!

Check out our services and other great resources in the links below.

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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!

SOURCES:

www.FDA.gov

www.drugs.com

Through the FDA, Dr. Berne’s Whole Health has issued a recall of their eye drops. Dr. Berne’s Organic Castor Oil Eye Drops, MSM DROPS solution, and MSM MIST solution may be contaminated with fungus and bacteria that cause serious infections. Upon inspection, MSM drops 5% were found to be contaminated, and out of an abundance of caution, Dr. Berne’s Whole Health has decided to do a massive recall of several products.

At this time, there have been two reports of adverse events related to the contaminated drops.

SUMMARY

Date of Recall:

Announced: August 26, 2023

Public Notification: August 26, 2023

Name(s) of Drug:

MSM 5% Solution Eye Drops

MSM 15% Solution Eye Drops

Castor Oil Eye Drops

MSMS MIST Drops 5% Solution

Company Name:

Dr. Berne’s Whole Health Products

Manufacturer: Sun Star Organics

Drug Indication:

Dry Eyes

Product Description

The eye drops are packaged in 30mL/1oz bottles distributed in individual boxes. Each bottle and container are individually labeled with the brand name, product name, and dosage. Products were sold at www.drsamberne.com and www.amazon.com.

Reason for Recall

A random inspection of the drops found that one lot of the MSM 5% drops were contaminated with fungi and bacteria that may cause severe eye infections and damage. So far, two reports of adverse events related to the contaminated eye drops have been reported.

Impacts

Consumers who continue using the drops could contract serious, life-threatening infections that may lead to blindness. Symptoms of eye infection include:

• Pain
• Eye Discharge
• Blurred Vision
• Light Sensitivity
• Watery Eyes
• Red Eyes
• Itchy
• Teary Eyes
• Blindness

Lot Information

Consumers should locate any Dr. Berne’s products they currently own. At this time, all lots of Dr. Berne’s eye drop solutions listed are being recalled. If your medication is on the list, you must take additional steps to participate in the recall procedures.

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

1. Call your doctor right away. Ask for a new prescription or recommendation to replace your recalled medication and report any changes in your symptoms.
2. Monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
3. Consumers should contact Dr. Berne’s Whole Health Products at 1 (877) 239-37777. They are available Mon-Fri from 9:00 am to 5:00 pm (MT). You can also contact them via email at  hello@drsamberne.com. All refund requests should be made to sales@sunstarorganics.com. Products may be returned to Sun Star Organics, 988 Main Street, Orange, CA 92867.
4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Dr. Berne’s Whole Health Products at 1 (877) 239-37777, or you can utilize hello@drsamberne.com to contact them via email. Returns and refunds can be initiated through sales@sunstarorganics.com. Notify them of any recalled batches that have already been sold to consumers.
3. Notify affected consumers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Dr. Berne’s Whole Health Products at 1 (877) 239-37777, or you can utilize hello@drsamberne.com to contact them via email. Wholesalers can initiate returns and refunds initiated through sales@sunstarorganics.com.
3. Notify the manufacturer of recalled batches already shipped to retailers.
4. Notify affected retailers of recalled batches that they have already or will receive.
5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal to the healthcare industry and the general public alike. We publish this blog to spread useful and practical information to help you stay safe, informed, and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to help!

Check out our services and other great resources in the links below.

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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!

The FDA, along with Ozona Organics, LLC, has issued a recall of select lots of GoHealthy Liquid Probiotics. The digestive health supplements marketed for use by infants, toddlers, kids, and adults have the potential to cause serious illness due to microbial contaminations. All lots of the company’s line of probiotics for pigs, horses, dogs, and cats are being recalled as well.

As of the writing of this notice, no adverse effects have yet been reported.

SUMMARY

Date of Recall:

Announced: August 1, 2023

Public Notification: August 1, 2023

Name(s) of Drug:

GoHealthy Liquid Probiotics

Ozona Organics Probiotics

Company Name:

Ozona Organics, LLC

Drug Indication:

Digestive Health

Product Description

The probiotics marketed for human consumption come packaged in 2-oz or 4-oz blue, glass bottles, or 16-oz blue, plastic bottles. The line of products marketed for animal use comes in 1-gallon white, plastic bottles.

Products were distributed online at www.ozonaorganics.com, www.gohealthy.us, www.walmart.com, and www.amazon.com.

Reason for Recall

Ozona Organics, LLC has found a high amount of water activity in the formula. This could lead to unwanted microbial growth and therefore illness in consumers who ingest the product.

Impacts

Consumers who continue to ingest the probiotics could experience illness leading to symptoms such as:

• Nausea
• Vomiting
• Diarrhea
• Fever
• Fatigue
• Dizziness
• Loss of Appetite
• Abdominal Pain
• Dehydration

Symptoms could last up to 7 days.

Lot Information

Consumers should locate the bottle in which the medication comes to compare lot numbers, manufacturing dates, and expiration dates with the chart below. If you find your lot number, manufacturing date, and expiration date on the chart below, your medication is affected by the recall and you will need to take additional steps in order to ensure that your health is not affected and to take part in recall procedures.

All lots of Ozona Organics probiotics for dogs, cats, and pigs are included in the recall.

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

1. 1. Call your doctor right away and report any changes in your symptoms.
   2. Continue to monitor your health for any adverse symptoms over the next week and notify your physician if any concerns are noted.
   3. Consumers should contact Ozona Organics, LLC at 1-325-203-4026. They are available Mon-Fri from 9:00am to 4:00pm (CT).
   4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
   5. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

Retailer

1. 1. Examine all inventory and remove stock that is affected by the recall immediately.
   2. Contact Ozona Organics, LLC at 1-325-203-4026. Notify them of any recalled batches that have already been sold to consumers.
   3. Notify affected consumers of recalled batches that they have already or will receive.
   4. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

Wholesaler

1. 1. Examine all inventory and remove stock that is affected by the recall immediately.
   2. Contact Ozona Organics, LLC at 1-325-203-4026. Notify them of any recalled batches that have already been shipped to retailers.
   3. Notify affected retailers of recalled batches that they have already or will receive.
   4. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal to the healthcare industry and the general public alike. We publish this blog in order to spread useful and practical information to help you stay safe, smart and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to help!

Check out our services and other great resources in the links below.

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Tammy McKinney, RN, creator of HelpfulHospiceNurse is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!

A recall of the popular birth control, Tydemy, has been issued by Lupin Pharmaceuticals, Inc. and the FDA after poor stability testing results. The manufacturer noted that after 1 year, there was a significant decline in ascorbic acid, leading to a reduction in effectiveness. As of the writing of this notice, no adverse effects have been reported. Unexpected pregnancies may have occurred, however.

SUMMARY

Date of Recall:

Announced: July 29, 2023

Public Notification: July 31, 2023

Name(s) of Drug:

Tydemy™

Drospirenone, Ethinyl Estradiol and Levomefolate Calcium, 3mg/0.03mg/0.451mg

Levomefolate Calcium 0.451mg

Company Name:

Lupin Pharmaceuticals, Inc.

Drug Indication:

Pregnancy Prevention

Product Description

Tydemy is packaged in blister packs within a printed sleeve. The sleeve is orange and blue in color and bears the name Tydemy™ as well as lot information.

Reason for Recall

Decreased effectiveness caused by the instability of the ingredients may lead to unexpected pregnancies.

Impacts

Consumers who continue to utilize this contraceptive may experience unexpected pregnancies during its use.

Lot Information

Consumers should locate the package in which the medication comes to compare NDC, UPC, and lot numbers, as well as expiration dates, with the chart below. If you find your NDC number, UPC lot number, and expiration date on the chart below, your medication is affected by the recall. You will need to take additional steps in order to ensure that your health is not affected and to take part in recall procedures.

FDA.gov

Have you found that your birth control medication is part of the recall? Here’s what you should do:

Consumers

NOTE: CONSUMERS SHOULD NOT DISCONTINUE THIS MEDICATION ABRUPTLY. SPEAK TO YOUR DOCTOR BEFORE MAKING ANY CHANGES.

Sudden discontinuation of this medication may cause side effects. These may include:

• Weight changes
• Acne
• Changes in Menstrual Cycle
• Changes in Mood
• Changes in Sex Drive
• Unexpected Pregnancy

If you find that your lot of medication is part of this recall, do the following:

1. Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any unexpected symptoms.
2. Monitor your health for signs of pregnancy and notify your physician if you think you may be pregnant.
3. Consumers should contact Inmar Rx Solutions at 1-866-480-8206. They are available Mon-Fri from 9:00am to 5:00pm (EST). If necessary, reimbursement can be provided.
4. If you are currently experiencing or have experienced an adverse reaction to this medication, notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
5. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

Retailer

1. Examine all inventory and remove stock that is affected by the recall immediately.
2. Contact Inmar Rx Solutions at 1-866-480-8206. Notify them of any recalled batches that have already been sold to consumers.
3. Notify affected consumers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

Wholesaler

1. Examine all inventory and remove stock that is affected by the recall immediately.
2. Contact Inmar Rx Solutions at 1-866-480-8206. Notify them of any recalled batches that have already been shipped to retailers.
3. Notify affected retailers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal to the healthcare industry and the general public alike. We publish this blog in order to spread useful and practical information to help you stay safe, smart and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to help!

Check out our services and other great resources in the links below.

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Tammy McKinney, RN, creator of HelpfulHospiceNurse is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!

COzempic, a drug created to aid in the control of blood sugar for adults with Diabetes, Type 2 has become much sought after due to its propensity for triggering weight loss. Those who can afford the nearly $1,000 monthly are scrambling to get a prescription. However, weight loss isn’t the drug’s only side effect.

The European Union is investigating Ozempic, manufactured by Novo Nordisk, after three patients reported experiencing suicidal thoughts while taking it. As more data is collected, it’s found that what was previously thought of as a safe way to lose weight may be harmful. The New York Times published an article this week discussing the dangers of the drug’s effects on adults over 65 who are losing muscle mass in addition to fat, causing them to become frail.

Those hoping to circumvent the dangers of this pharmaceutical drug with a more “natural” approach may find themselves taking Berberine, a plant-based supplement known as “Nature’s Ozempic.” Unfortunately, insufficient data is available to substantiate its claims or confirm its safety.

About the Products

Ozempic, whose generic name is semaglutide, is a prescription medication delivered by weekly self-injection. Intended for patients with Type 2 Diabetes, it is often prescribed for patients who are obese and struggle with weight loss.

Ozempic can cost upwards of $1,000 monthly for those without insurance, but with insurance coverage can cost as little as $25.

Reason for Notice

While Ozempic is approved by the FDA for use, it is relatively new and, as more data is released, is potentially dangerous.

Impacts

Patient’s using Ozempic (semaglutide) may experience dangerous side effects such as suicidal ideation (thoughts of harming oneself).

If you or anyone you know is having thoughts of harming themselves, call the crisis hotline for help immediately

DIAL 988 FOR HELP

Consumers

At this time, Ozempic is not being recalled. If you are taking the medication under the guidance of a physician, continue to follow their direction. Call the crisis help center at 988 immediately if you experience any thoughts of self-harm, then notify your physician.

If your physician directs you to stop taking the drug, contact MedWaste Management for assistance with disposal.

Retailer

At this time, continue to distribute Ozempic per your protocol.

If a patient reports any thoughts of self-harm, stay with the patient and notify the crisis center at 988.

We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal in the healthcare industry and the general public. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to help!

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Images sourced from: https://www.ozempic.com/why-ozempic/how-ozempic-works.html

Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!

PRIME, the hottest energy drink of 2023 according to many online, is under scrutiny by lawmaker Chuck Schumer, and he is demanding that the FDA investigate. His concerns are valid, with each drink containing 200mg of caffeine, what you’ll find in 6 cans of cola. While it may not sound like much, receiving a high dose of caffeine quickly can be deadly.

How popular is it?

With the brand selling over $250 million worth of the energy drink in the first year through a successful ad campaign with Logan Paul and KSI, kids and teens are scrambling to get a taste. Should parents and consumers be concerned? Definitely!

What’s the big deal?

Caffeine is a drug, a stimulant to be exact. While it has some medical uses and can give a user a pick-me-up in small doses, it can be lethal, causing:

• Heart arrhythmias (irregular heartbeat)
• High blood pressure
• Anxiety
• Diarrhea
• Insomnia (inability to sleep)
• Death

Kids and teens are particularly sensitive to the effects of caffeine, often experiencing the side effects more so than adults.

Will the FDA pull it from shelves?

Can we expect to see an investigation and recall? Possibly. On the one hand, several similar products are available on the market today, some with even higher concentrations of caffeine. Fast Twitch by Gatorade and Celcius both contain the same 200mg of caffeine as PRIME. Bang Energy tops the field at 300mg of caffeine per can. If a recall is ordered on one, it would likely need to be ordered on them all.

There is a possibility that they’ll go forward with the investigation. With Chuck Schumer, a well-known politician, making it his mission to have these drinks investigated, likely garnering support from parents and healthcare professionals alike, the FDA will need to respond in some way. In 2018, a similar fad hit the market in the form of concentrated caffeine powders and liquids that could be used to caffeinate just about anything. The FDA investigated and warned companies to remove products from the shelves or face serious consequences.

It’s also possible that the FDA will forego the investigation, opting to issue a statement warning parents and children about the dangers of caffeine.

What happens in the meantime?

Regardless of their decisions, parents and children must know that energy drinks are not intended for individuals under 18. They are also designed to be sing-dose, meaning consumers should avoid caffeine for 24 hours after drinking one.

We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal to the healthcare industry and the general public alike. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to help!

Check out our services and other great resources in the links below.

Medical Waste Disposal Services

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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!

Images sourced from: https://www.amazon.com/Prime-Hydration-Raspberry-Strawberry-Watermelon/dp/B0BRLB16X8

A recall of the popular drug, Albuterol Sulfate, has been issued due to a defect in the inhaler valve that causes the medication to leak rather than be delivered to the patient. This could be deadly for those who use these “rescue inhalers” for Asthma, Chronic Obstructive Pulmonary Disease (COPD), or symptoms such as shortness of breath due to infection. As of the writing of this notice, no adverse effects have yet been reported. However, patients using this medication should immediately obtain a replacement if their inhaler is listed in the recall (see below).

SUMMARY

Date of Recall:

Announced: July 6, 2023

Public Notification: July 7, 2023

Name(s) of Drug:

Albuterol Sulfate, 90mcg

Company Name:

Cipla

Drug Indication:

Asthma

COPD

Shortness of Breath

Product Description

The product is distributed in aluminum containers that hold 17ml of medication. Each container comes with a dose counter, plastic actuator, and dust cap. They are packed within a cardboard box that indicates the name of the medication, dosage, etc.

Image sourced from: https://www.ciplaalbuterolhfa.com/HCP/index.html

Reason for Recall

While no adverse reactions have been reported yet, the device used to deliver the medication is faulty. It can result in patients not receiving emergency medication when needed.

Impacts

Consumers who continue to utilize the faulty actuator may find that their asthma, COPD, or other respiratory symptoms worsen, which could lead to respiratory failure (an inability to breathe) and death.

Lot Information

Locate the box in which the medication came or the aluminum bottle containing the drug. Compare with product name, batch number, and expiration dates below. If your prescription is included in the recall, see below for further information on obtaining a replacement and disposing of the recalled product.

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

NOTE: CONSUMERS SHOULD NOT DISCONTINUE THIS MEDICATION ABRUPTLY.

SPEAK TO YOUR DOCTOR BEFORE MAKING ANY CHANGES.

If you find that your lot of medication is part of this recall, do the following:

1. Call your doctor immediately. Ask for a new prescription to replace your recalled medication and report any changes in your symptoms.
2. monitor your health for any adverse symptoms over the next week and notify your physician if any concerns are noted.
3. Consumers may contact Cipla Customer Service at 1-844-247-5287. They are available Mon-Fri from 8:30 am to 5:00 pm (EST). You can also contact them via email at cipla.cs@cipla.com.
4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Cipla Customer Service at 1-844-247-5287 or via email at cipla.cs@cipla.com. Notify them of any recalled batches that have already been sold to consumers.
3. Notify affected consumers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Cipla Customer Service at 1-844-247-5287 or email them at cipla.cs@cipla.com. Notify them of any recalled batches that have already been shipped to retailers.
3. Notify affected retailers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal in the healthcare industry and the general public alike. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to help!

Check out our services and other great resources in the links below.

Medical Waste Disposal Services

MedWaste’s Blog Index

Medical Waste Regulations

MedWaste’s Product Store

Learn How To Properly Manage & Dispose of Household Medical Waste

Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn.

The FDA has issued a stern warning letter to Warrior Labz Sarms after discovering that the company is illegally selling and distributing prescription drugs to the general public. On its website and social media, the company indicates that its drugs are “for research purposes” but also promotes the medications for erectile dysfunction, muscle building, decreased inflammation, and more.

Furthermore, the company manufactures its medications in higher concentrations, sometimes double what the FDA found safe, leaving consumers at increased risk of life-threatening reactions, including death.

Warrior Labz Sarms has 15 days to develop and implement a corrective action plan. Failure to do so will result in further action, including an immediate drug recall. As of the writing of this notice, the company continues to manufacture and distribute the drugs illegally.

SUMMARY

Date of  Warning Notice:

Announced: June 12, 2023

Name(s) of Drug:

Various Injectibles and Consumables

Company Name:

Warrior Labz Sarms

Drug Indication:

Varies

About the Products

The FDA is investigating Warrior Labz Sarms for its complete line of drugs. Below is a sampling of those drugs and their promoted use.

FDA

Reason for Warning

Drugs within their catalog are not approved by the FDA for human consumption and injection. Furthermore, the organization appears to promote its drugs for human use while using a disclosure stating that they are for research purposes only. Company reviews show that consumers purchase and use the drugs for themselves, even though they are not approved and are sold at dangerously high doses.

Impacts

Using unapproved drugs places the consumer at extreme risk of life-threatening reactions. For instance, sildenafil interacts with medications that lower blood pressure. Use without the oversight of a licensed physician can lead to a dangerous drop in blood pressure, dizziness, fainting, or death.

Furthermore, Warrior Labz Sarms is distributing and promoting the use of selective androgen receptor modulators (known as SARMs). Bodybuilders commonly use these drugs to increase muscle mass and decrease fatigue. Due to the dangers associated with its use, including life-threatening liver injury and heart attack, and the limited evidence of its benefits, SARMs are illegal in the US.

This notice is urgent and consumers who have purchased substances from Warrior Labz Sarms should monitor Med Waste Management for upcoming drug recalls related to the investigation.

Consumers

1. Currently, the FDA has issued no official guidance on recalls or discontinuations of the medications. However, the drugs sold by Warrior Labz Sarms can harm your health. Contact your physician immediately if you have been utilizing the drugs for further instructions.
2. If you use any medications from this company, monitor your health for adverse symptoms and notify your physician of any concerns.
3. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and inform the FDA by calling 1-800-332-1088 or completing an online reporting form.
4. If your physician advises you to dispose of the medication, contact MedWaste Management for information and assistance with disposal.

Retailer

1. Track drug recalls through the FDA or Med Waste Management websites.
2. Notify affected consumers when the FDA announces the formal recall.
3. Contact MedWaste Management for information and assistance with disposing of medications if necessary.

We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal in the healthcare industry and the general public. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to help!

Check out our services and other great resources in the links below.

Medical Waste Disposal Services

MedWaste’s Blog Index

Medical Waste Regulations

MedWaste’s Product Store

Learn How To Manage & Dispose of Household Medical Waste Properly

Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!

Children’s Bacaolinita Supplement Recalled

Procaps S.A. DE C.V.’s  Bacaolinita Children’s Supplement has been recalled through the FDA, effective immediately. The supplement is marketed as a vitamin supplement for children with slow growth or decreased appetite. However, the product is noted to contain an inactive ingredient, PEG 40 hydrogenated castor oil that has not been declared on the label.

PEG 40 hydrogenated castor oil is typically used during manufacturing as a surfactant, emulsifier, or cleansing agent and is not approved for internal use or consumption. Studies on the effects of the substance on the human body are limited, but some medication interactions have been noted in the past and certain sensitive individuals, such as children are at risk of anaphylactic reactions when consuming the product.

SUMMARY

Date of Recall:

Announced: June 7, 2023

Public Notification: June 7, 2023

Name(s) of Recalled Drug:

Bacaolinita

Company Name:

PROCAPS S.A. DE C.V.

Laboratorios Lopez’s

Drug Indication:

Health Supplement for Children with decreased appetite or slow growth.

Recalled Product Description

The product is sold in a dark, amber-colored, plastic, 8oz bottle within a blue box adorned with the name of the supplement and an image of two children.

Reason for Recall

No adverse reactions have been reported as of the writing of this notice. However, the consumption of PEG 40 hydrogenated castor oil can result in medication interactions and anaphylaxis, leading to possible death.

Impacts

Consumers who utilize the recalled product are at risk of an anaphylactic reaction. Symptoms of this serious reaction include:

• Clammy Skin
• Hives
• Vomiting
• Confusion
• Anxiety
• Lightheadedness
• Wheezing
• Loss of Consciousness
• Fast Heartrate
• Death

Lot information

The recalled supplement was distributed throughout Delaware, Rhode Island, Texas, and California, both online and via retail locations.

Consumers should locate the box in which the supplement is packaged to compare UPC, lot numbers, and expiration dates with the chart below. If you find your UPC, lot numbers and expiration date listed on the chart below, your supplement is affected by the recall and you will need to take additional steps in order to ensure that your health, or the health of your child is not affected and to take part in recall procedures.

FDA.gov

Have you found that your supplement is part of the recall? Here’s what you should do:

Consumers

If you find that your lot of supplement is part of this recall, do the following:

1. Call your doctor right away. Notify them of any portion that has been consumed and any symptoms that may have occurred.
2. Continue to monitor your health for any adverse symptoms over the next week and notify your physician if any concerns are noted.
3. Consumers should return the product to the place of purchase for a full refund.
4. Consumers may contact the manufacturer with any questions at 1-561-444-8188. They are available Mon-Fri from 8:30am to 5:00pm (EST). You can also contact them via email at recall@jmm.one.
5. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
6. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

Retailer

1. Examine all inventory and remove stock that is affected by the recall immediately.
2. Contact the manufacturer with any questions at 1-561-444-8188 or you can utilize recall@jmm.one to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
3. Notify affected consumers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

Wholesaler

1. Examine all inventory and remove stock that is affected by the recall immediately.
2. Contact the manufacturer at 1-561-444-8188 or you can utilize recall@jmm.one to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
3. Notify affected retailers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and/or assistance with disposal of the recalled medication.

We are MedWaste Management – California’s medical waste disposal experts!

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal to the healthcare industry and the general public alike. We publish this blog in order to spread useful and practical information to help you stay safe, smart and healthy!

Call us with any questions or to start service at (866) 254-5105. We are always happy to help!

Check out our services and other great resources in the links below.

Medical Waste Disposal Services

MedWaste’s Blog Index

Medical Waste Regulations

MedWaste’s Product Store

Learn How To Properly Manage & Dispose of Household Medical Waste

Tammy McKinney, RN, creator of HelpfulHospiceNurse is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics.

You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!