A trio of companies have issued separate voluntary recalls for treatments of heart disease, diabetes and dermatitis, according to details posted on FDA’s website. The recalls were due to possible device delivery failure, stability of product and the presence of bacteria.
Padagis issued a voluntary recall of three lots of nitroglycerin lingual spray, which is used to relieve or prevent chest pain due to coronary artery disease in adult patients. The recall was issued after a complaint was filed that a unit did not dispense. The company said it hasn’t received any reports of adverse events related to the recall.
The recall is only for the company’s 12-g spray bottle and not its 4.9-g spray medication and covers lots 150892, 153199 and 156041 that were distributed nationwide in the U.S. The packaging on the recalled lots lists Perrigo Company PLC.
In addition, Viona Pharmaceuticals issued a voluntary recall of 33 lots of metformin hydrochloride extended-release tablets USP 750-mg, which is used to help treat diabetes. The company said the recall was the result of an out-of-specification test result that found the presence of the carcinogen N-nitrosodimethylamine (NDMA).
The recalled products were manufactured by Cadila Healthcare in India for U.S. distribution by Viona. The company said it has not received any reports of adverse effects related to the recall.
Metformin is used by adults with Type 2 diabetes to improve blood glucose levels in conjunction with diet and exercise. The recalled lots are packaged in HDPE bottles of 100 tablets, under NDC 72578-036-01.
Finally, Taro Pharmaceuticals issued its voluntary recall for one lot of clobetasol propionate ointment labeled Lot AC13786 with an expiration date of December 2022. 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. Taro said it has not received any adverse event reports related to the recall.
Patients who are immunocompromised or who have psoriasis, sunburn or skin abrasions are at risk if the bacteria circulates in the blood stream due to the enhanced absorption triggered by the corticosteroid component of the cream. 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.