Recall Alert: Heart Disease, Diabetes and Dermatitis Treatments Recalled

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FDA Trio of Recalls: Heart Disease, Diabetes and Dermatitis Overview:

• Who: Three companies have issued separate voluntary recalls for treatments of heart disease, diabetes and dermatitis, according to the Food & Drug Administration.
• Why: The recalls are due to device delivery failure, the presence of a carcinogen and the presence of bacteria.
• Where: The recalls are nationwide .

Carcinogens, dangerous bacteria and faulty packaging are behind three pharmaceutical companies’ most recent recalls for treatments of heart disease, diabetes and dermatitis, according to the Food & Drug Administration (FDA).

In three separate notices posted to the FDA website between Dec. 27 and Dec. 28, the companies revealed they were each issuing voluntary recalls for their products after one manufacturer found its product contained a carcinogen, another found its product contained a dangerous bacteria and another discovered a faulty dispenser. 

The companies are not currently facing legal action over the recalls, but Top Class Actions follows recalls closely as they sometimes end in class action lawsuits.

Heart Disease Treatment Recall

On Dec. 27, Padagis issued a recall of three lots of nitroglycerin lingual spray, which is used to relieve or prevent chest pain due to coronary artery disease. 

The recall was issued after a complaint was filed that a unit did not dispense the required medication. If the product does not deliver the appropriate amount of nitroglycerin, the user will continue having chest pain. 

The recall says that if the patient does not feel better after using the product three times in 15 minutes, they should “promptly seek medical attention.” There have been no reports of adverse effects due to the issue so far, the company said. 

The recall includes the company’s 12g spray bottle,in lots 150892, 153199 and 156041. The product was distributed nationwide.

Diabetes Treatment Recall

On Dec. 28, Viona Pharmaceuticals issued a recall of 33 lots of its metformin hydrochloride extended-release tablets USP 750 mg used to help treat diabetes. Metformin is used by adults with Type 2 diabetes to improve blood glucose levels.

The recall was prompted after a test result found the presence of the probable human carcinogen N-nitrosodimethylamine.

Patients who have received impacted lots of Metformin Hydrochloride Extended-Release Tablets USP 750 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment.

The company said it has not received any reports of adverse effects related to the recall so far.

Dermatitis Treatment Recall

On Dec. 27, Taro Pharmaceuticals issued a recall for one lot of clobetasol propionate ointment. The ointment is used to treat various forms of dermatitis.

The company issued the recall after routine testing by the manufacturer found the presence of Ralstonia pickettii bacteria. The bacteria can cause invasive infections such as sepsis, pneumonia, meningitis and inflammation to bones and bone marrow as well as infection of joint fluid and joint tissue, the FDA said.

Taro said it has not received any adverse event reports related to the recall so far. The recalled product is labeled Lot AC13786 with an expiration date of December 2022. 

For more on the latest product safety recalls, click here. 

Are you affected by the recalls? Let us know in the comments! 

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