Category Archives: Product Recalls

eye dropper close to eye

Puriton Eye Relief Drops Can Harm Your Eyes.

Kadesh Incorporation Issued a Voluntary Nationwide Recall of Puriton Eye Relief Drops. The complete statement can be found on the FDA’s recall page.

The recall was due to non-sterile conditions during production.

When the FDA inspected the production site, the investigators discovered that the necessary production controls and conditions for sterility were not being observed.

Opthalmic drugs are required to be sterile in particular, because using a non-sterile eye drop can potentially threaten the vision of the consumer due to the risk of an eye infection. Also, the pH factor of the eye drops can cause direct destruction of tissues in the anterior chamber, cornea, and even deeper in the eye.

This can potentially cause scarring, vision loss, or glaucoma.

To date, there have been no reports of adverse effects related to the Puriton Eye Relief Drops.

Purtion Eye Relief Drops is an over-the-counter homeopathic eye drop product. Its uses include temporary relief of burning and irritation of the eye due to dryness and temporary relied of discomfort due to minor irritations to the eye, like wind and sun exposure. Other uses were the relief of redness, watery eyes, inflamed eyes, itching, burning, tearing eyes, eye pain, and lubricant.

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton EyeRelief Drops , 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level.

It is packaged in a 15 ml plastic bottle, and was distributed nationwide through the company’s online stores and the retail distributors they work with. All distributors and customers are being notified by letter and Kadesh is arranging for the return of all the recalled products.

As of now, the product cannot be found anywhere online, neither on the Puriton website nor online markets like Amazon.

Anyone who has recalled eye drops should stop usage or sale of the product.

Consumers with questions regarding this recall can contact the Recall Department at contact@puriton.us, available Monday through Friday, from 9 am to 6 pm (Pacific Time).

Product may be returned to Kadesh Inc. by mail:

4731 Lincoln Way, Garden Grove, CA 92841.

Anyone who experienced any problems that may be related to the use of the non-sterile product should contact their healthcare provider.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

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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!

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dangerously high blood pressure

Losartan: Another Blood Pressure Medication Is Being Recalled

The FDA is recalling Irbesartan and Losartan, more angiotensin II receptor blockers (ARBs), after discovering traces of NDEA in them.

This new recall is for Losartan sold by Sandoz.

The recall is only for the 100mg/25mg tablets and does not involve other versions of the losartan drug.

This recall impacts less then 1% for the total losartan drug products in the US market. However, it is only the tip of the iceberg for pharmaceutical products  from the same manufacturer found tainted with amounts NDMA and NDEA that are not safe by the FDA’s standards.

The active ingredient in the recalled lot of losartan tested positive for NDEA.

NDEA is a suspected human and animal carcinogen. It was found within an ingredient that was made and supplied by the Zhejiang Huahai Pharmaceutical Company Co. Ltd. This same company supplied the tainted active ingredient used in the recalled lots of valsartan.

After the European Medicines Agency, (EMA), and then the FDA, confirmed the presence of NDMA and NDEA impurities in Valsartan, the FDA launched an investigation, including an inspection of the Zhejiang Huahai facility. They found traces of both NDEA and NDMA.

At the end of September, the FDA placed the Chinese company on an import alert, which means that any  active pharmaceutical products or finished products from the company would not enter the United States.

Valsartan is used in blood pressure medication and some vaccine products, among others.

The FDA is testing all ARBs- for NDEA and NDMA impurities and is keeping an ongoing list of recalled medicines and those that are not going to need to be recalled.

In August, 2018, FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, released a statement on the FDA’s ongoing investigation into valsartan impurities and recalls.

They described what caused the impurity in the drugs, what the FDA is doing about it, and the risk assessment for patients who have been taking the tainted drug.

The scientists working for the FDA estimated that,  “if 8,000 people took the highest valsartan dose (320 mg) from NDMA-affected medicines daily for four years, (this is the amount of time they estimated the affected drugs were being marketed), there may be one additional case of cancer over the lifetimes of these 8,000 people beyond the average cancer rate among Americans.”

That estimate was based on the highest daily dose, however many people may have taken lower doses, and therefore their risks would be less.

FDA expects the actual cancer risk to most consumers to be lower than the estimate.

The losartan recall is for lot number JB8912. If you are taking losartan, you can check the lot number on the bottle and see if the numbers match.

If your drug is on the recall list, the FDA suggests that you continue to take it until you can get a replacement from a Doctor or Pharmacist.

Questions regarding this recall can be directed to Sandoz Inc. at 1-800-525-8747 Monday-Friday 8:30 AM – 5:00 PM (EST) or email usdrugsafety.operations@novartis.com.

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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!

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woman with pill

Drug Recall: ORTHO-NOVUM

Janssen Pharmaceuticals has issued a voluntary recall for three lots of ORTHO-NOVUM tablets. The packages had the wrong instructions for the Veridate® dispenser included in them.

Only three lots of ORTHO-NOVUM were affected: ORTHO-NOVUM® 1/35, ORTHO-NOVUM® 7/7/7, ORTHO-NOVUM® 7/7/7. The FDA website has detailed information about the specific lots.

ORTHO-NOVUM® (norethindrone/ethinyl estradiol) is a contraceptive. It is used as birth control, to prevent pregnancy, and at times used as hormonal treatment for severe acne.

ORTHO-NOVUM® pill packs contain 28 pills with active medication. 21 have active medication/hormones, and 7 pills are inert reminder pills.

The potential risk of taking ORTHO-NOVUM® without the appropriate instructions for correct use of the Veridate® dispenser pack is that the pills would be taken in the incorrect order.

That could be harmless and still provide an adequate dose. However, the other risk is that the inactive “reminder” pill would be taken on days that the active pill is necessary. This could lead to breakthrough bleeding and, in a case of active ovulation, could lead to unintended pregnancy.

The lots with the inaccurate patient instructions were distributed only in the United States, to wholesalers, distributors, and pharmacies. Janssen Pharmaceuticals have already sent out letters and notifications to return the affected products.

Consumers with ORTHO-NOVUM® product from the affected lots can get the correct instructions for the Veridate® dispenser pack at https://www.janssen.com/us/our-products. If they have any concerns about their treatment program, they can talk to their prescribing medical professional. Consumers should not stop taking the product and if they do miss a dose, they should follow the instructions included in the packet for missing a dose.

The ORTHO-NOVUM® product itself remains safe and will be effective with the appropriate dispenser instructions. 

No other ORTHO® contraceptive products beyond those three lots are impacted by this recall action.

Any questions regarding this recall can be addressed to Janssen Pharmaceuticals by phone: 1-800-526-7736 (1-800-JANSSEN) Monday through Friday from 9:00 am to 8:00 pm ET. Consumers should contact their healthcare provider if they have experienced any problems that might be related to using this 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.

________

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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food poisoning, listeria

Product Recall: Fried Onions with Listeria and Salmonella

Possible Salmonella and Listeria Monocytogenes contamination is affecting multiple products and crossing State lines.

The reason for the recall was contaminated ingredients sold and shipped by McCain Foods. Initially, they identified the contamination in their onion ingredients.

First, “Out of an abundance of caution”,  Hy-Vee recalled the following products from all of its stores:

Hy-Vee Bacon Wrapped Cowgirl Chicken Grillers, Hy-Vee Fire Roasted Tomato, Spinach, Mozzarella Twice Baked PotatoHy-Vee Cowgirl Chicken Griller PattyHy-Vee Gourmet Steakhouse Mushroom & Swiss BurgerHy-Vee Ground Beef Sliders Mushroom & Swiss

The impacted products had a “Best If Used By” date of Oct. 22, 2018, or sooner

The instructions for customers who bought any of the recalled products was to avoid consuming them, throw them out, or return them to the local Hy-Vee store for a refund.

Questions about Hy-Vee recalled products will be addressed 24 hours a day with Hy-Vee Customer Care representatives at 1-800-772-4098.

The FDA has a full list of the Hy-Vee recalled products on their site.

Since then, the recall has spread to a dozen U.S. food manufacturers including Bakkavor Foods, Envolve Foods and Ruiz Food Products. The food makers notified the U.S. Department of Agriculture about products they shipped that could include ingredients such as corn, diced onions and other vegetables possibly tainted with bacteria – all provided from McCain Foods.

McCain Foods, which has headquarters in Canada and offices in Illinois, said they identified a potential health risk related to their fire roasted, caramelized, or sauteed frozen vegetable and fruit products that were produced at their Colton (California) facility.

Included in the recall:

Salads, wraps, burritos and pizza sold at Harris Teeter, Kroger, Whole Foods, 7-Eleven, Ralphs, Trader Joe’s, Walmart, Simple Truth, and other major retailers.

The Fresh Market said they removed some pizza and pasta salad products and self-serve portions from the shelves of 161 stores in 22 states.

For a complete list of affected products, check the USDA’s current recalls site.

According to McCain Foods and the USDA, there have been no confirmed reports of adverse reactions due to consumption of any of the recalled products as of now.

Listeriosis is a food-borne infection caused by Listeria bacteria that is commonly found in water, soil, and feces. Humans are infected when they consume foods that harbor the bacteria.

The most common foods to cause listeriosis outbreaks are deli meats and unpasteurized dairy products. However, many other foods have also been found to spark outbreaks, including caramel apples, cantaloupe, and cabbages fertilized by sheep manure.

Adults who are healthy and have strong immune systems are less at risk of listeriosis. Pregnant women are more susceptible to infection and can pass the infection to the fetus or suffer complications or miscarriage. Other people who have an increased risk of Listeria infection are the elderly, children or people who are immuno-compromised.

Severe Listeria infections can cause gastroenteritis (“stomach flu”), bacteremia, sepsis, meningitis, pneumonia, osteomyelitis and endocarditis.

An estimated 1,600 people get Listeriosis each year in the U.S., and about 260 die from it, according to the CDC. 

Listeria and Salmonella infections usually resolve on their own without treatment. The best defense is prevention. Heat all foods that may be harboring bacteria.

There are also natural remedies that assist with the symptoms and with overcoming the infection that have been proven useful.

With proper rest, care and in the worst case, with treatment, This Too Shall Pass.

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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!

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valsartan pill bottle

Drug Recall: Valsartan

The U.S. Food and Drug Administration has twice expanded its recall of several drug products containing the active ingredient Valsartan from Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd., as well as valsartan/hydrochlorothiazide from Solco and Teva.

The reason for the recall is the presence of N-nitrosodimethylamine (NDMA).

NDMA was found in the batches that contained the valsartan ingredient manufactured by  Zhejiang Huahai Pharmaceuticals, Linhai, China.

NDMA is classified as a probable human carcinogen.

The presence of NDMA was unexpected, said the FDA, and is possibly related to changes in how the active substance was manufactured.  According to the EPA, NDMA — which was formerly used in rocket fuel, among other things — can be an unintended byproduct of wastewater treatment plants that use chemical compounds called chloramines for disinfection.

Zhejiang Huahai has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products. 

The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.

The FDA will continue to investigate this issue and provide additional information when it becomes available.

The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.

You can see a list of the recalled medications, as well as a list of products containing valsartan that have not been recalled, on the FDA’s website. Only products contaminated with NDMA are being recalled — not all valsartan tablets.

Not all valsartan products contain NDMA.

Valsartan is used for the treatment of hypertension (high blood pressure) and for the treatment of heart failure. It is also indicated as a treatment for left ventricular failure and left ventricular dysfunction following myocardial infarction. In combination with hydrochlorothiazide, it is used in the treatment of hypertension.

If you are taking valsartan, you should continue taking the medicine until you can determine if you need a replacement product. You can do this by checking the list of affected companies and batches on the FDA’s website.

The risk of stopping treatment can be more harmful to your health than taking the contaminated valsartan for just a bit longer, until you can get it replaced.

Contact your Doctor or Pharmacist. You may get a prescription for a different medication that treats the same indications, or a refill of valsartan medication from a batch that was not affected by the recall.

CBS News has a segment playing on the valsartan recall.

Customers and patients with Medical-related Questions, information about an Adverse Event or other questions about the Teva product’s being recalled should contact Teva’s Medical Information by phone at: 888-838-2872, option 3, option 4, then option 1.

  • Live calls are received Monday-Friday, 9:00AM-5:00PM Eastern Time with Voicemail available 24 hours/day, 7 days/week or email druginfo@tevapharm.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to Teva directly at 888- 838-2872 or to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

_______

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!

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

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child on sand

Cortaid Recall: Anti-Itch Application May End Up Needing Antibiotic

Product Quest has issued a Cortaid recall, among other products. An internal quality review revealed possible contamination of Cortaid Anti-itch Cream products with  Pseudomonas aeruginosa.

The recall covers all lots and expiration dates of Cortaid Creams.

This includes Cortaid 12-hour Advanced Anti-Itch Cream, sold in 1.5-ounce tubes; Cortaid Maximum Strength Cream, sold in 1-ounce tubes; and Cortaid Intensive Therapy Cooling Spray (2-ounces). Anyone with these products should return them to the store for a full refund.

Pseudomonas aeruginosa is a common bacteria that can cause pseudomonas infection. Most pseudomonas infections occur in hospitalized patients and/or with compromised or weakened immune systems. An estimated 51,000 healthcare-associated P. aeruginosa infections occur in the United States each year. More than 6,000 (13%) of these are multidrug-resistant, with roughly 400 deaths per year attributed to these infections. 

Multidrug-resistant Pseudomonas was given a threat level of serious threat in the CDC AR Threat report.

Healthy people can also develop mild illness with Pseudomonas aeruginosa, especially when exposed through water. Ear infections are a common reaction, especially in children. Exposure to the bacterial through inadequately chlorinated hot tubs or swimming pools can result in generalized skin rashes as well. Patients using infected extended-wear contact lenses have reported eye infections.

To the best of Product Quest’s knowledge, the company has not received any reports of adverse events related to this recall so far.

Cortaid is not the only product that Product Quest is recalling for  Pseudomonas aeruginosa contamination. All its nasal products and baby oral gels are suspect to the bacteria and are being recalled. In August, Product Quest Manufacturing recalled nasal sprays sold as name brands and as the house brands for Walgreens, CVS, Meijer, Dollar General, Rexall, Family Dollar, Rite-Aid and Harmon.

On September 17, Valeant Pharmaceuticals announced the recall of all Cortaid creams, and on September 24, they recalled Ocean Saline Nasal Spray.

MediNatura recalled 19 lots of two nasal sprays, a throat spray and a cough syrup for a “possible microbial contamination” in the water-based products. Clearlife Nasal Spray, Reboost Nasal Spray, Reboost Throat Spray, each in 20 ml bottles, and 125 ml bottles of Reboost Cough Syrup are involved in the recall.

“Administration or use of drug products with microbial contamination, could potentially result in increased infections that may require medical intervention,” MediNatura’s website recall notice says.

To date, the company has not received any reports of illness or injury.

KIngBio has recalled Baby Teething Liquids for microbial contamination, and many other water-based products, due to the same bacteria in their water.

Product Quest is notifying its customers by oral and written communication and is arranging for return/replacement etc. of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to the place of purchase or discard the product.

Consumers with questions regarding this recall can contact Product Quest Manufacturing LLC at (386) 239-8787, Monday through Friday from 8 am to 4 pm, EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or 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.

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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hand holding nasal spray

Product Recall: CVS Health 12 Hour Sinus Relief Nasal Mist

CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid in a spray bottle with a nozzle that fits up your nostril, is having problems with lot number 173089J. There was microbiological contamination in that lot. The microbe contamination was identified as Pseudomonas aeruginosa.

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid to the consumer level. 16,896 units were released with UPC code 50428432365. The affected CVS Health 12 Hour Sinus Relief Nasal Mist lot is Lot # 173089J, EXP 09/19.

The product can be identified by a white nasal spray bottle and an orange label with Sinus Relief stated in white with CVS Health on top left.

The box has the same colors and words on it. On the side panel of the carton, the affected lot would have the words: “Lot 173089J” and “EXP 09/19” coded on it.

The nasal decongestant is packaged in 0.5 fluid ounce bottles, in individual folding carton.

Product was distributed Nationwide to retail outlets.

 Repetitive use of a nasal spray containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening.

Infection is usually benign, but in certain patient populations, such as those with cystic fibrosis or  immuno-compromised.

The company has not received any reports of adverse events related to this recall.

So far, anyways.

Product Quest is notifying its customers by oral and written communication and is arranging for return/replacement etc. of all recalled products.

Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to the place of purchase or discard the product.

Consumers with questions regarding this recall can contact Product Quest Manufacturing LLC at (386) 239-8787, Monday through Friday from 8 am to 4 pm, EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or 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 Onlinefda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form fda.gov/MedWatch/getforms.htm 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.

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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!

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

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blood pressure meter

Product Recall: Valsartan

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines .

The products subject to recall  are packed in bottles. These lots were distributed Nationwide to Teva’s Direct Accounts (Wholesale/Distributor/Retail/Repackagers/VA Pharmacy, et. al).

These were distributed under the Actavis label in the U.S. They are being recalled due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) that was manufactured by Zhejiang Huahai Pharmaceutical.

Teva is not the only company to recall Valsartan. Major Pharmaceuticals, and Solco Healthcare are also recalling Valsartan/ Hydrochlorothiazide due to the same impurity detected.

The FDA action came after 22 other countries issued recalls involving 2,300 valsartan batches sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta.

What Is Valsartan?

Valsartan is used for the treatment of hypertension (high blood pressure) and for the treatment of heart failure. It is also indicated as a treatment for left ventricular failure and left ventricular dysfunction following myocardial infarction. In combination with hydrochlorothiazide, it is used in the treatment of hypertension.

Why Is It Being Recalled?

The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution,  and industrial processes. It can be used to make liquid rocket fuel, softeners and lubricants, among other products. It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing.a

N- nitrosodimethylamine (NDMA) has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

The toxin affects the liver and causes liver fibrosis or scarring and liver tumors in rats.Exposure to high levels of NDMA may cause liver damage in humans, according to the US Environmental Protection Agency.

To date, TEVA has not received any reports of adverse events related to this recall.

What Should You Do?

Don’t stop taking your blood pressure meds!!

First of all, not all medicines containing valsartan are involved in the recall.

Check the FDA recall site or call your pharmacy to find out if the bottle you have is from a contaminated lot before taking further action.

Valsartan alternatives are available.

Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.

Questions, concerns, adverse reactions or quality problems experienced with the use of this product may be reported to Teva directly at 888- 838-2872 or to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

_________

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!

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

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Product Recall: MyNicNaxs.com

MyNicNaxs, LLC, Deltona, FL is voluntarily recalling all lots of dietary supplements distributed nationwide to consumers and stores. All lots means every bottle that went out of their warehouse, of every product they were selling.

Unfortunately, they are not the first company who needed to recall weight loss and sexual enhancement products. These niches seem to be rife with undeclared, misleading, and plain dangerous pills. Dozens of weight-loss and immune-system supplements on the market are illegally labeled and lack the recommended type of scientific evidence to back up their purported health claims.

Cautionary Tale

MyNicNaxs, LLC, Deltona, FL, is- or was- a company selling both dietary supplements for weight loss and sexual enhancement. Unfortunately, the dietary supplement (or “chinese medicine”) was  a misleading name for products that contained undeclared active pharmaceutical ingredients.

Drugs, in other words.

The FDA went to court to complain. First, they alleged that certain MyNicNaxs products are drugs under the FD&C Act because they are intended to cure, mitigate, treat or prevent disease.

Second, the drugs were misbranded because their labeling was false and misleading in that it didn’t  declare certain active pharmaceutical ingredients. The labeling failed to bear adequate directions for use, and/or the drugs are dangerous to health when used as recommended in the labeling.

The following permanent injuction required the defendants to stop distributing any unapproved new drugs or misbranded drugs. They were prohibited from receiving, manufacturing, holding and distributing any drugs or dietary supplements until the FDA puts out a written notification that they are in compliance of the FD&C Act and its regulations, and that they may resume operations.

The MyNicNax website is down, but the pinterest account is still up with photos of the products and promotional photos.

Harmful Substances

The FDA discovered the presence of Sildenafil, Sibutramine, Diclofenac and/or Phenolphthalein in the dietary supplements. This rendered the supplements as an unapproved drug for which safety and efficacy have not been established.

These products were distributed from January 2013, to December 2017, though the website http://www.mynicnaxs.com.

The undeclared drugs can cause serious health risk. A)Some of them are cancerous, and B)Taking drugs unknowingly can interfere and interact with other drugs the person is taking. Or can expose the consumer to a drug that is harmful or dangerous in their particular situation… a drug they would never take if they knew it was in the magic pill.

The following drugs were detected in the products:

Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated Sibutramine poses an increased risk of heart attack and stroke.

Phenolphthalein is a known carcinogen (cancer causing agent) It was once an ingredient used in over-the-counter laxatives. It is no longer approved for marketing in the United States.

Sildenafil is the active pharmaceutical ingredient in Viagra (PDE-5 inhibitor), a drug approved by FDA for the treatment of erectile dysfunction. PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin). PDE-5 inhibitors can lower blood pressure to dangerous levels.

Diclofenac is a non-steroidal anti-inflammatory drugs (NSAIDs) found in FDA-approved drugs that are used to treat pain and inflammation associated with several conditions. NSAIDs could lead to serious GI trouble, like bleeding, ulceration, and fatal perforation of the stomach and intestines.

Patients who are already taking medication that could cause bleeding may increase their risk for bleeding significantly.

This is a list of all the website products, as listed on the FDA website: 26 products in all that did not disclose drugs in the ingredient list on the bottle.

Product Description API Found in FDA Lab Results
Platinum Maximum Strength Blue Pill Version;
30 capsules; 500mg each
Sibutramine and Phenolphthalein
Platinum Maximum Strength Blue Pill Version;
30 capsules; 500mg each
Sibutramine and Phenolphthalein
Slimming Plus Advanced Weight Loss; 30
capsules; 500mg each
Sibutramine and Phenolphthalein
African Viagra – sexual performance
enhancement product; 4500mg x 2
Sildenafil
GINSENG – sexual performance enhancement
product; 300mg/tablet x 10 tablets
Sildenafi
African Superman – sexual performance
enhancement product; 2900mg x 8 tablets per
blister pack
Sildenafil
Old Chinese – sexual performance enhancement
product; 19800mg x 10 capsules
Sildenafil
Lean Extreme Max; 30 capsules; 400mg each Sibutramine
X-treme Beauty Slim; 30 capsules; 350mg each Sibutramine
African Superman – Top-Class Permanence
Tablet; 2900mg x 8 tablets
Sildenafil
Slim Evolution – 100% Natural Ingredients; 30
capsules; 350mg each
Diclofenac
Meizitang Strong Version capsules packed in a
non-flexible clear bottle with a green screw-on
top
Sibutramine
Magic Slim capsules packed in a non-flexible
white bottle with a white screw-on top
Sibutramine
Slim Xtreme capsules packed in a non-flexible
white bottle with a white screw-on top
Sibutramine
Meizi Evolution capsules were packed in a non-
flexible clear bottle with a blue screw-on top
Sibutramine
SlimEasy Herbs capsules packed in blister
packaging and placed in a white box with black
labeling
Sibutramine
Hokkaido – capsules packed in blister packaging
in pink box with black labeling
Phenolphthalein
Super Fat Burning Bomb capsules in blister
packs, packaged in a red box with black labeling
Sibutramine and Phenolphthalein
FRUTA Bio blister packs, packaged in a
yellow/green box with green labeling
Sibutramine and Phenolphthalein
JIANFEIJINDAN Activity Girl – blister packs,
packaged in a white/pink box with pink labeling
Sibutramine
Reduce Weight FRUTA PLANTA blister packs,
packaged in a yellow/green box with green
labeling
Phenolphthalein
Fat Loss Slimming Beauty – 30 capsules in
blister packs packaged in yellow/black box -500
mg
Sibutramine and Phenolphthalein
Fruta Planta -blister packs packaged in
yellow/green box with green labeling
Sibutramine and Phenolphthalein
Botanical Slimming – 100% Natural Soft gel; 30 soft gels; 650mg each packaged in a green bag with yellow and white lettering
Slim Body – Dietary Supplement;100% Herbal Slimming Formula; 30 capsules; 6x5x300mg blister packs, packaged in blue and red box

If you have bought any of these products, you are advised to immediately discontinue use.

There have been no reports of adverse effects so far. If you think you have experienced adverse effects, speak to your health care provider immediately. You should also report to the FDA MedWatch Adverse Event Reporting Program by filling out the online form, or sending the form by regular mail or fax.

For any questions regarding this recall, contact Mike Banner by phone 407-791-3597 or Chevonne Torres 386-337-8142, Monday to Friday, 09:00am-5:00 pm, Eastern Time.

 

 

 

Nasal spray held up to nose

Product Recall: Fluticasone Propionate Nasal Spray USP 50

Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays is used to treat seasonal allergic rhinitis and perennial allergic rhinitis. It is also perscribed for managing sinus pain and sinus pressure – the kind associated with allergic rhinitis for patients of certain ages.

Fluticasone Recall:

Apotex Corp., a company that produces Fluticasone Proprionate Nasal Spray, issued a voluntary recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays . The reason was potential for small glass particles.

The company is recalling one lot of the product that has reached the consumer level. The particular lot of the Nasal Spray was found to contain small glass particles that were blocking the actuator and impacting the function of the spray pump. The issue was discovered after a customer complained.

Always complain if you buy a pharmaceutical product and it doesn’t work the way it it supposed to, even if the flaw seems to be merely technical. The entire lot of it may be faulty and you may be helping many people by alerting the company to the problem.

There is also potential risk that patients using the product would be exposed to the glass particles-i.e., spray them up their noses. That would cause local trauma to the nasal mucosa, or “mechanical irritation” that may cause worse nose problems than the patient had before. Imagine what a particle of glass could do if it got stuck in the sinuses or the nasal passages.

To date, Apotex Corp. hasn’t gotten any reports of adverse effects related to this problematic lot of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays . The affected lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays was distributed nationwide to wholesalers and distributors. Apotex Corp. notified wholesalers and distributor by  letter to arrange for return of any recalled product

What To Do:

If you are a consumer with an inventory of the lot subject to this recall, stop using or distributing the units remaining in your possession and put them aside immediately. Notify your Doctor or Healthcare Professional about this recall if you’re reading this and think they may be distributing this product. Notify anyone that has bought or received this product from you about the recall.

Call GENCO Pharmaceutical Services, a subsidiary of FedEx Supply Chain (GENCO) at 1- 877-475-5863 (7:00am – 5:00pm, CST Monday thru Friday), to arrange for return of the product.

Customers with questions regarding this recall can contact Apotex Corp:

1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday)

or email address UScustomerservice@Apotex.com.

Contact your physician immediately if you have experienced any problems that may be related to taking or using this drug product.

You can report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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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Product Recall: Simvastatin (Zocor)

Simvastatin is a generic form of Zocor. Zocor  is a hypolipidemic, or anti-cholesterol, drug. It is a member of a class of drugs called statins. It’s made from the aspergillus terreus fungus and is used to reduce low-density lipoprotein (LDL) cholesterol. High LDL cholesterol levels (“bad” cholesterol) are associated with increased risk of stroke, heart attack, and cardiovascular death.

The World Health Organization (WHO) considered Zocor one of the safest, most effective, essential medications on the market. In 2005, Zocor earned its manufacturer, Merck, more than $4.3 billion in sales to an estimated 2.1 million patients.

Simvastatin Recall:

To date, there have been ten recalls of Simvastatin. The biggest Simvastatin recall so far affected just over 54,000 bottles, which is relatively minor compared to other generic medications. (Lisinopril had over a million bottles recalled at once.) The biggest recall was the  2015 Class III recall by Micro Labs, involving 54,096 bottles. The reason for the Simvastatin Recall was impurities in the pills.

FDA Warnings:

There is no complete Simvastatin Recall from the market.

However, due to FDA warnings, there are strict restrictions on the drug, especially the 80mg dose.

In 2011, the FDA announced changes for the safety labels of Simvastatin, because of increased risk of injury while taking the highest dose of 80 milligrams.

Risk of Injury is particularly high within the patient’s first 12 months of Zocor use at the 80mg dosage. The FDA advised that new patients should not be prescribed the 80mg dosage. Also, patients using 40mg doses of Zocor should not be increased to 80mgs. Instead, they should be switched to an alternative statin drug.

In 2012, the FDA issued a Drug Safety Communication warning users of interactions between protease inhibitors and statins. Findings indicated that using both simultaneously leads to increased risk of muscle injury. The safety labels of the HIV protease inhibitors as well as the affected statins have been updated to communicate the risk to patients.

All data came from the FDA’s Adverse Event Reporting System. This system is one of the main ways the FDA evaluates medicines after they have hit the market.

Simvastatin Side Effects:

Common side effects are headaches, constipation, and nausea. Simvastatin is contraindicated for patients with kidney trouble and pregnancy.

Other side effects include:

  • Joint pain
  • Nausea
  • Dizziness
  • Constipation and other gastrointestinal problems
  • Liver damage brought about by increased liver enzymes. This is a serious side effect that must be addressed immediately.
  • Muscle Pain

There have also been some findings on Simvastatin Weight Gain.

The weight gain may also be linked to sleep problems that can be set off by Simvastatin crossing into the brain. The resulting sleep disturbance can result in insulin resistance, weight gain, and generally affecting the patient’s quality of life in a negative way. 

The more severe side effects of Zocor occur in the muscles. Patients taking Zocor may develop myopathy, a condition that causes weakness and pain in the muscles. The muscle damage is often caused by the drug’s interaction with other medicines.

Some people are just genetically predisposed to this kind of muscle damage disease.

A risky, much less common side effect is Rhabdomyolysis, a fatal muscular disease. During rhabdomyolysis, the body’s muscles break down excessively and release myoglobin into the blood called myoglobin which can cause kidney damage. In severe cases, rhabdomyolysis can lead to kidney failure and death.

Patients taking Zocor who experience muscle pain or tenderness, fatigue, weakness, or dark urine should seek immediate medical attention.

Taking the 80mg dose of Simvastatin (the highest approved dose)have been found to be at greater risk for severe side effects, especially during the first year of treatment.

A European study shows that patients taking statins may have a nine-percent increased risk for developing type 2 diabetes and/or liver disease.

All of these findings caused the FDA to issue a recommendation: sharply limit the use of the 80mg simvastatin dose.

Merck Misconduct:

Merck has been accused of misconduct by failing to warn the public of the risks associated with using Zocor. Allegedly, Merck was negligent in its duties to its customers by not warning users of the severe side effects in time to prevent them. Merck is accused of purposely withholding knowledge about the risky side effects of Zocor.

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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!

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

Medical Waste Disposal Services 

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product recall rubber stamp

Product Recall: Azithromycin

Azithromycin (or Zithromax, Zmax) is an antibiotic used to treat a wide variety of mostly bacterial infections. Its indications include bronchitis, ear infections, community-acquired pneumonia, acute bacterial sinusitis, pharyngitis/tonsillits, urethritis, cervitis, genital ulcer disease, and acute bacterial exacerbations of chronic obstructive pulmonary disease. In 2011, approximately 40.3 million individuals in the U.S. received and outpatient perscription for azithromycin. Azithromycin is considered by the World Health Organization to be an essential medicine.

Risky Side Effects:

Common side effects are nausea, headache, and diarrhea.

Risky side effects can include severe allergic reactions that include hives, swelling, difficulty breathing, and anaphylaxis. In rare cases, azithromycin can cause radiation recall dermatitis.

On 3/12/2013, the FDA issued a Safety Announcement about Azithromycin, following a New England Journal of Medicine study that compared the risks of cardiovascular death in patients treated with four different antibacterial drugs (azithromycin, amoxicillin, ciprofloxacin (Cipro) and levofloxacin (Levaquin), or no antibacterial drug. The study reported an increase in cardiovascular deaths, and the risk of death from any cause, in patients treated with a 5-day course of azithromycin (Zithromax)  and levofloxacin (Levaquin), compared to persons treated with amoxicillin, ciprofloxacin, or no drug.

FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms

The problem noted was a prolongation of the QT interval. This affects the heart’s electrical cycle. Severe disturbance the QT interval may lead to cardiac failure and/or death. QT prolongation can affect any patient prescribed to Zithromax.

Patients already presenting with heart complications that are prescribed azithromycin are especially at risk for sudden death. There is also a higher risk for patients who have a family history with heart disease. The risk of sudden death is minimal, but Doctors have have suggested Zithromax recall to be an appropriate response.

Why was it Recalled?

While a Zithromax recall for all of the medication has not been issued,  Zithromax recalls were issued for specific lots or batches.

Mostly, the reasons for recalls have been Inadequate Investigation of Consumer Complaints.

Other reasons cited for recalls were Failed Impurities/Degradation Specifications.(One batch was manufactured with high dosages of the active ingredient and was a public safety hazard) Lack of Assurance of Sterility and Stability, and Penicillin Contamination.

There have been 11 Azithromycin recalls from 2012-2017. In 2016,  PD-Rx Pharmaceuticals conducted two Class II nationwide recalls of azithromycin tablets. In total, more than 62,500 bottleswere included in the 2016 recall, according the U.S. Food and Drug Administration.

Additional Information for Healthcare Professionals:

When considering treatment options for patients already at risk for cardiovascular events, consider the risk of fatal heart rhythms with azithromycin. Also, the potential risk of QT prolongation with azithromycin should be appropriately considered.

Additional Information for Patients taking Azithromycin:

*Seek immediate care if you experience dizziness, shortness of breath, irregular heartbeat or fainting while taking azithromycin.

*Do not stop taking azithromycin without discussion with your health care professional. Talk to your health care professional if you have any concerns about your perscribed drugs.

*Report any adverse effects with the FDA MedWatch program.

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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!

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

Medical Waste Disposal Services 

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