On the heels of a carcinogen scare that drove the company to pull three lots of a short-term ulcer treatment in January, Mylan has issued another recall, this time over particles found in a sample vial of one of its injectable antibiotics.
Mylan will recall one lot of injectable daptomycin after finding particulate matter in a single-dose vial produced at the company's specialty formulation center in India, the company said.
Mylan is pursuing the recall down to the consumer level, notifying distributors and reaching out to customers by letter for return of the potentially contaminated doses. The batch in question was distributed nationwide to wholesalers and retail pharmacies between April 2020 and May 2020, the FDA said.
Currently, the company says it hasn't received any reports of side effects or serious reactions related to the recalled daptomycin, used to treat serious skin infections and staphylococcus aureus bloodstream infections in adults. But injecting a solution with visible particulates could lead to local irritation, microvascular obstruction, allergic reactions and more, Mylan warned.
Several other drugmakers, including Fresenius Kabi and Hikma, have run into trouble with particulate contamination this year, and Takeda had to pull its supply of rare disease med Natpara last year for the same reason.
For Mylan's part, it's the second drug recall this year. In early January, the drugmaker issued a recall on three lots of nizatidine capsules—used to treat duodenal ulcers—after trace amounts of a likely carcinogen, N-Nitrosodimethylamine (NDMA), were discovered in the active pharmaceutical ingredient (API) in tested batches of the drug. Those ingredients were manufactured by Indian drugmaker Solara Active Pharma Sciences.
Mylan's nizatidine recall followed an FDA report in September 2019 that flagged trace amounts of NDMA in generic and branded versions of the popular heartburn med Zantac (ranitidine), which led to a spate of recalls. Back in 2018, the agency had spurred a recall of certain "sartan"-based blood pressure meds contaminated with NDMA, before following up in April 2019 with a list of 40 generics deemed safe for use.
Meanwhile, other major drugmakers such as Takeda, Hikma and Fresenius Kabi have recently recalled their own drugs because of particle contamination.
Last month, Japan-based Takeda was slapped with an FDA warning letter after it failed to identify the cause of black particulates finding their way into vials of an unnamed injectable drug. The FDA levied a host of other sanitation complaints against the drugmaker.
In May, German drugmaker Fresenius Kabi recalled 13 lots of its anti-inflammatory ketorolac tromethamine for injection following the discovery of carbon, silicon, and polyamide particulates in eight vials of the drug. And two months before that, Hikma's U.S. operation halted production on the same drug after finding black, gelatinous particles in certain drug vials.