A voluntary recall has been issued by Ascend Laboratories, LLC for specific lots of Dabigatran Etexilate Capsules (a generic substitute for Pradaxa) due to detection of an impurity within the medication. It has been found that a dangerous level of a nitrosamine called N-nitroso-dabigatran, a substance known to cause cancer is present in the drug. At the time of the writing of this notice, no adverse reactions have been reported but patients are being cautioned to follow proper procedures if their stock of medication is affected.

SUMMARY

Date of Recall:

Announced: March 22, 2023

Public Notification: March 22, 2023

Name(s) of Drug:

Dabigatran Etexilate

Company Name:

Ascend Laboratories, LLC

Drug Indication:

Atrial Fibrillation

Deep Vein Thrombosis (DTV)

Pulmonary Embolism (PE)

Prevention of Blood Clots in those who present a high risk

Product Description

The drug is distributed by licensed pharmacies in white, plastic bottles. Information regarding lot number, NDC number, expiration date and count-per-bottle can be located on the label. All affected lots are contained within the 75mg and 150mg capsule distributions.

Reason for Recall

The particular lots involved in the recall have been found to contain a dangerously high level of the nitrosamine, N-nitroso-dabigatran, a substance that has been found to increase the risk of cancer. While the nitrosamine is not dangerous in small doses, continued exposure is not recommended.

Impacts

Consumers may not experience any noticeable symptoms if their medication is affected. However, it is important to participate in the recall if your drug is listed as continued use can increase the risk of cancer.

Lot information

Consumers should locate the bottle in which the medication comes to compare NDC and lot numbers as well as expiration dates with the chart below. If you find your NDC number, lot number 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 take part in recall procedures and ensure that your health is not affected.

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.

DO NOT DISCONTINUE USE UNTIL ADVISED BY YOUR PHYSICIAN TO DO SO.

Discontinuation of this medication may put you at risk for clotting due to underlying conditions.

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.
2. Consumers may contact Ascend Laboratories, LLC at 1-877-272-7901. They are available 24/7.
3. 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.
4. 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 Ascend Laboratories, LLC at 1-877-272-7901. They are available 24/7. 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 Ascend Laboratories, LLC at 1-877-272-7901. They are available 24/7. 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!

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A voluntary recall has been issued by Perrigo for limited quantities of their Gerber Good Start SoothePro TM Powdered Infant Formula due to possible presence of Cronobacter Sakazakii bacteria which can lead to fever, poor feeding, excessive crying or low energy in infants who are exposed. At this time of this notice, no adverse events have been reported and no formula has tested positive for the bacteria, but out of an abundance of caution, the company has chosen to move forward with the recall.

SUMMARY

Date of Recall:

Announced: March 17, 2023

Public Notification: March 17, 2023

Name(s) of Product:

Gerber Good Start SoothePro TM Powdered Infant Formula

Company Name:

Perrigo

Indication:

Infant feeding

Product Description

Product is distributed in cans in 12.4oz, 30.6oz and 19.4oz sizes with a blue lid and Gerber logo on the front.

Reason for Recall

There is reason to suspect that the formula processed in a Wisconsin manufacturing plant may have been exposed to the Cronobacter Sakazakii bacteria. While the bacteria does not cause any symptoms in healthy adults, it can be problematic for infants, especially those who are premature or immunocompromised.

Impacts

Infants fed the formula may experience fever, poor feeding, excessive crying or low energy as a result of exposure to the bacteria.

Lot information

Consumers should locate their can of formula and check for “use by” dates as well as lot codes located on the bottom of the package. Only the following listed lots and use by dates are affected:

Gerber® Good Start® SootheProTM 12.4 oz:
300357651Z – USE BY 04JUL2024
300457651Z – USE BY 05JUL2024
300557651Z – USE BY 06JUL2024
300557652Z – USE BY 06JUL2024
300757651Z – USE BY 08JUL2024
300857651Z – USE BY 09JUL2024
301057651Z – USE BY 11JUL2024
301057652Z – USE BY 11JUL2024
301157651Z – USE BY 12JUL2024

Gerber® Good Start® SootheProTM 30.6 oz:
301357652Z – USE BY 14JUL2024
301457652Z – USE BY 15JUL2024
301557651Z – USE BY 16JUL2024

Gerber Good® Start® SootheProTM 19.4 oz:
301557652Z – USE BY 16JUL2024I

Fda.gov

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

Consumers

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

1. Stop feeding your child this formula immediately and replace with a formula that is not part of the recall (note that this recall applies to only a small number of lots and expiration dates).
2. Continue to monitor your baby’s health for any adverse symptoms over the next week and notify their physician if any concerns are noted.
3. Consumers should contact the Gerber Parent Resource Center at 1-800-777-7690 for a refund. They are available 24/7.
4. If your child is currently experiencing or has experienced an adverse reaction to this formula (listed above), notify your child’s 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 formula.

Retailer

1. Examine all inventory and remove stock that is affected by the recall immediately.
2. Contact Gerber Parent Resource Center at 1-800-777-7690. They are available 24/7. 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 formula.

Wholesaler

1. Examine all inventory and remove stock that is affected by the recall immediately.
2. Contact Gerber Parent Resource Center at 1-800-777-7690. They are available 24/7.
3. Notify them of any recalled batches that have already been shipped to retailers.
4. Notify affected retailers of recalled batches that they have already or will receive.
5. Contact MedWaste Management for information and/or assistance with disposing of the recalled formula.

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!

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Stratford Care USA, Inc has issued an immediate recall of their Omega-3 Supplements for cats and dogs after receiving a report of a dog exhibiting signs of Vitamin A toxicity. The product is sold under various names and through channels such as veterinary clinics as well as online and in-person retailers including Amazon and Chewy.

SUMMARY

Date of Recall:

Announced: March 9, 2023

Public Notification: March 10, 2023

Name(s) of Drug:

See listing below…

Company Name:

Stratford Care USA

Drug Indication:

Supplementation

Product Description

The supplements were packaged in white bottles with various styles of labels affixed. The bottom of the container was marked with lot numbers and expiration dates.

Reason for Recall

At this time, one report has been made of a dog experiencing symptoms of a Vitamin A overdose.

Impacts

Pets who are experiencing a Vitamin A overdose, may experience symptoms of general unwell feelings, nausea, refusal to eat, weakness, tremors, peeling skin, convulsions, paralysis and death.

Lot information

Recalled lots:

Lot 31133, Expiration Date 04/13/2023

Lot 30837, Expiration Date 10/26/2022

Because this supplement was sold under various brand names, it is important to reference the chart below to determine if your pet’s supplement may be included:

www.fda.gov

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

Consumers

1. Stop administering the supplement to your pet right away.
2. Notify your pet’s veterinarian. Monitor your pet’s health over the next week and notify the veterinarian of any change in their behavior or health.
3. Consumers may contact Stratford Care, USA at 1-877-498-2002. They are available Mon-Fri from 9:00am to 5:00pm (EST). You can also notify them via email at Adverseevents@stratfordrx.com if your pet has experienced any symptoms related to using the supplement. If you purchased the medication directly from Stratford Care, USA, refund requests can be sent to refunds@stratfordrx.com.
4. If your pet is currently experiencing or has experienced an adverse reaction to this supplement, notify your veterinarian immediately and report it to 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. Retailers may contact Stratford Care, USA at 1-877-498-2002. They are available Mon-Fri from 9:00am to 5:00pm (EST). You can also notify them via email at Adverseevents@stratfordrx.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/or assistance with disposing of the recalled medication.

Wholesaler

1. Examine all inventory and remove stock that is affected by the recall immediately.
2. Wholesalers may contact Stratford Care, USA at 1-877-498-2002. They are available Mon-Fri from 9:00am to 5:00pm (EST). You can also notify them via email at Adverseevents@stratfordrx.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/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!

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Natural Solutions Foundation has issued a voluntary recall of their product, Dr. Rima Recommends, The Silver Solution after the U.S. Department of Justice filed a civil complaint in the New Jersey District Court due to the company making unsubstantiated claims that the product could prevent or even cure Covid-19. The drug was not approved by the FDA and has not been proven to be an effective treatment for Covid-19. At the time of the writing of this notice, no adverse effects have been reported by consumers, but there are concerns that patients may not seek necessary and life-saving treatment for the illness if they believe that this product is sufficient.

SUMMARY

Date of Recall:

Announced: March 7, 2023

Public Notification: March 8, 2023

Name(s) of Drug:

Dr. Rima Recommends

Dr. Rima Recommends, Nano Silver 10ppm Dietary Supplement

Dr. Rima Recommends, The Silver Solution

Company Name:

Natural Solutions Foundation

Drug Indication:

Prevention/Treatment of Covid-19 and other illnesses.

Product Description

The product is distributed in 16oz bottles labeled as, “Dr. Rima Recommends.”

Reason for Recall

At this time, Natural Solutions Foundations has provided no proof of their claims that the drug can prevent or even cure Covid-19. The drug is not approved for use by the FDA. No adverse effects have been reported at this time, but there are concerns that consumers may not receive necessary or life-saving treatments for their Covid-19 infection if they believe the product is sufficient treatment.

Impacts

Consumers should discontinue use of the product immediately and if they believe that they may have a Covid-19 infection, should notify their physician immediately and seek an approved treatment.

Lot information

All lots are being recalled at this time. They were sold to the public between January 22, 2020 and December 27, 2021.

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

Consumers

If you find that you have a bottle of the product that is part of this recall, do the following:

1. Call your doctor right away if you are experiencing any symptoms of Covid-19, including shortness of breath, cough or loss of taste/smell.
2. Discontinue use of the product.
3. Consumers may request a refund by returning any unused portion of the drug to the foundation by mailing it to Natural Solutions Foundation c/o Ralph Fucetola, 58 Plotts Road, Newton, NJ 07860. Include your return mailing address and name and a refund check will be processed and mailed out to you within 14 days of product receipt.
4. Any additional questions concerning the medication or recall can be emailed to the foundation at admin@inhere.org .
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. Request a refund by returning any unused portion of the drug to the foundation by mailing it to Natural Solutions Foundation c/o Ralph Fucetola, 58 Plotts Road, Newton, NJ 07860. Include a return mailing address and name and a refund check will be processed and mailed out within 14 days of product receipt.
3. Contact the foundation with any further questions at admin@inhere.org .
4. Notify affected consumers of recalled batches that they have already or will receive.
5. 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. Request a refund by returning any unused portion of the drug to the foundation by mailing it to Natural Solutions Foundation c/o Ralph Fucetola, 58 Plotts Road, Newton, NJ 07860. Include a return mailing address and name and a refund check will be processed and mailed out within 14 days of product receipt.
3. Notify affected retailers of recalled batches that they have already or will receive.
4. Contact the foundation with any further questions at admin@inhere.org .
5. 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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PrimeZEN Black 6000 male enhancement capsules are being recalled after they have been found to be tainted with Sildenafil and Tadalafil. These contaminants can cause dangerous interactions with prescriptions drugs and can lead to a life-threatening hypotension (low blood pressure). Continue reading Men’s Erectile Enhancement Capsules Recalled! Dangerous Interactions Possible! →

Global Pharma Healthcare has issued an immediate recall of all lots of their Artificial Tears Lubricant Eye Drops within all current expiration periods. The drops have been found to contain a contaminant. As of the writing of this notice, 55 people have reported adverse effects related to these drops, including complete loss of vision, eye infections and even death.

SUMMARY

Date of Recall:

Announced: February 2, 2023

Public Notification: February 2, 2023

Name(s) of Drug:

EzriCare, LLC Artificial Tears Lubricant Eye Drops

Delsam Pharma Artificial Tears Lubricant Eye Drops

Company Name:

Global Pharma Healthcare

Drug Indication:

Dry Eyes

Irritated Eyes

Product Description

The eye drops are packaged in 15mL bottles that are distributed in individual boxes. Each bottle and box are labeled clearly with the name of the product and the dosage (10mg in 1mL).

Reason for Recall

55 people have reported infections, permanent loss of vision and even death after using the product. It is believed that a contaminate in the drops is causing the infection.

Impacts

Consumers who have used the eye drops should discontinue it’s use immediately and notify your medical provider. Monitor your overall health closely in coming weeks and notify your physician of any health related changes or concerns, particularly in relation to your eyes and vision.

Lot information

ALL lots within their current expiration period are being recalled. Any expired medication should always be disposed of properly.

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

 Consumers

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

1. Call your doctor right away. Notify them of your use of a recalled medication and report any changes in your vision or concerning symptoms related to your eyes or overall health.
2. Continue to monitor your health for any adverse symptoms over the next few weeks and notify your physician if any concerns are noted.
3. Consumers should contact Aru Pharma/Ezricare, LLC at 1-516-715-5181. They are available Mon-Fri from 11:00am to 4:00pm (EST). You can also contact them via email at arupharmainc@yahoo.com. DELSAM Pharma, LLC can be reached at 1-866-826-1306. They are available 11:00am to 4:00pm (EST) and their email is delsampharma@yahoo.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/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 Aru Pharma/Ezricare, LLC at 1-516-715-5181. They are available Mon-Fri from 11:00am to 4:00pm (EST). You can also contact them via email at arupharmainc@yahoo.com. DELSAM Pharma, LLC can be reached at 1-866-826-1306. They are available 11:00am to 4:00pm (EST) and their email is delsampharma@yahoo.com.
3. Notify the manufacturer of any recalled batches that have already been sold to consumers.
4. If possible, notify affected consumers of recalled batches that they have already or will receive.
5. 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 Aru Pharma/Ezricare, LLC at 1-516-715-5181. They are available Mon-Fri from 11:00am to 4:00pm (EST). You can also contact them via email at arupharmainc@yahoo.com. DELSAM Pharma, LLC can be reached at 1-866-826-1306. They are available 11:00am to 4:00pm (EST) and their email is delsampharma@yahoo.com.
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!

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IBSA Pharma Inc. has issued an immediate recall of a large number of batches of the medication TIROSING®-SOL due to potency issues. The affected lots have been found to be less potent than labeled, putting consumers at risk of decreasing T4 levels and return of their hypothyroid symptoms.

SUMMARY

Date of Recall:

Announced: January 31, 2023

Public Notification: February 1, 2023

Name(s) of Drug:

TIROSINT®-SOL

Levothyroxine Sodium Solution

(CAPSULES NOT AFFECTED. RECALL APPLIES TO SOLUTION ONLY)

Company Name:

IBSA Pharma Inc.

Drug Indication:

Hypothyroidism

Pituitary Thyrotropin Suppression

Thyroid Cancer (adjunct medication)

Product Description

TIROSINT®-SOL is a clear, odorless solution that is packaged in individual ampules for oral consumption. Each ampule is individually labeled with the product name and dosage. Each box of ampules is labeled with further information such as the NDS numbers, lot numbers, and expiration dates. This recall effects several different dosages of the medication, therefore all consumers of this product should confirm if their particular lots are listed.

Reason for Recall

The labeled amount of levothyroxine sodium in each ampule has been found to be less than 95% of what is indicated on the label. Particularly for patients who are sensitive to minor changes in their T4 levels, or patients who only take the medication on a weekly or bi-weekly basis, this variation in potency could lead to serious side effects.

Impacts

Consumers who have received an effected batch of the medication and who continue to utilize it may experience symptoms related to decreased T4 such as fatigue, increased sensitivity to cold, constipation, dry skin, slow heart rate, depression, swelling of the thyroid gland, puffy face, and/or hair loss.

Lot information

Consumers should locate the box in which the medication comes to compare NDC and lot numbers as well as expiration dates with the chart below. If you find your NDC number, lot number 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.

Note: Each strength is highlighted in a different color. Your box may have varying coloring, but you will find the NDC, Lot Number and Expiration Date in the same area on each package.

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.

Discontinuation of this medication may cause symptoms of hypothyroidism to return in a prompt and sometimes serious way. These may include:

• Bradycardia (slowed heart rate)
• Depression
• Fatigue
• Constipation
• Muscle weakness
• Irregular or heavy menstrual cycles
• Weight gain
• Difficulty tolerating cold
• Memory deficits
• Puffy face
• Dry skin
• Thinning hair

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 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 IBSA Pharma Inc. at 1-800-587-3513. They are available Mon-Fri from 9:00am to 7:00pm (EST). You can also contact them via email at medinfo@ibsapharma.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/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 IBSA Pharma Inc at 1-855-224-0231 or you can utilize IBSACS@Eversana.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/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 IBSA Pharma Inc at 1-855-224-0231 or you can utilize IBSACS@Eversana.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/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!

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Mylan Pharmaceuticals initiates voluntary nationwide recall of one lot of Alprazolam tablets, USP C-IV 0.5 mg, due to the potential of foreign substance.

Summary

Company Announcement

Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot (see table below) of Alprazolam Tablets, USP C-IV 0.5 mg, to the consumer/user level. This lot is being recalled due to the potential presence of foreign substance. Clinical impact from the foreign material, if present, is expected to be rare, but the remote risk of infection to a patient cannot be ruled out. To date, Mylan has not received any adverse events related to this batch.

Alprazolam Tablets are indicated for the management of anxiety disorder, the short-term relief of symptoms of anxiety, and the treatment of panic disorder, with or without agoraphobia.

Alprazolam Tablets, USP C-IV 0.5 mg, are packaged in bottles of 500. This batch was distributed in the U.S. between July 2019 and August 2019. The recalled lot is as follows:

Mylan has notified its distributors and customers by letter and is arranging for return of all recalled products. Following are actions for wholesalers, retailers and consumers:

• Wholesaler: Immediately examine your inventory, quarantine and discontinue distribution of these lots. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to mylan5924@stericycle.com within 10 business days. Stericycle will notify your retail level customers that received the affected batches.
• Retailer: Immediately examine your inventory, quarantine and discontinue distribution of these lots. Additionally, if you have further distributed the product, please identify the consumer and notify them immediately of this product recall. The consumer should be instructed to contact Stericycle at 1-888-843-0255 for the documentation packet to return the product.
• Consumer: Please contact Stericycle at 1-888-843-0255 for the documentation packet to return product to Stericycle.

Consumers with questions can contact Mylan Customer Relations at 800.796.9526 or customer.service@mylan.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration

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

Established in 2008, MedWaste Management brings great benefit to the healthcare industry and the general public alike. We publish this blog to to spread useful and practical information to help people stay safe, smart and healthy!

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

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TDBBS LLC Voluntary Recalls: Pig Ear Pet Treats; No Illnesses Reported; Strictly Precautionary.

This product was shipped to customers between April 22, 2019, and August 13, 2019.  Customers should dispose of any USA Thick Pig Ear 8 Pack and USA Thick Pig Ear 20 Pack from these shipments.

This recall is the result of routine sampling conducted by the Michigan Department of Agriculture & Rural Development. The sample bag tested positive for Salmonella. Salmonella can affect animals eating the products, and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or surfaces exposed to these products.

Summary

Company Announcement

Below is a company statement from TDBBS regarding a limited voluntary recall:

“As a strictly precautionary measure and because of our company’s strong commitment to the health and well-being of pets, TDBBS is conducting a voluntary recall of a limited distribution of two pig ear pet treat products sold through Amazon.com – USA Thick Pig Ear 8 Pack and USA Thick Pig Ear 20 Pack.

“This recall has been initiated due to possible Salmonella contamination, which poses a health risk. It is important to know that no illnesses have been reported, and the amount of affected product is minimal.

“TDBBS treats and chews are produced to robust safety and quality standards, using the most advanced food safety protocols. Our team is committed to doing its part to caring for the pets who enjoy our products. We regret the concern and inconvenience this recall creates for our customers.

“Our company has ceased the production and distribution of this product as we, in cooperation with the FDA, continue to investigate the situation further. TDBBS’s product safety team is conducting its own stringent review to identify what measures can be established to prevent this situation from recurring.

“Our safety teams have been rigorously testing our products and raw materials, working with independent testing firms and conducting an internal investigation within our supply chain to determine how this situation occurred. Nevertheless, we believe it is appropriate out of an abundance of caution to conduct this voluntary recall in cooperation with our customer.”

TDBBS provided the following information about specific products recalled:

Healthy people infected with Salmonella should monitor themselves for some or all the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product or a pet that has eaten the product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

All UPCs, Best By Dates and Lot Codes are located on the package back. Pictures of product labels are below.

Consumers may contact customer service at 877-483-5853, Monday to Friday 9-5pm or email TDBBS at customerservice@tdbbsllc.com.

Product Photos