For the second time this year, Mylan has issued a voluntary nationwide recall of one of its drugs.
The recall was triggered after Mylan identified the presence of a particulate in a single dose vial of injectable Daptomycin manufactured by Mylan Laboratory Limited’s specialty formulation facility in India. The company said that, so far, there have been no reports of harm associated with use of the medication. But exposure to the contaminant could cause “adverse serious events” including local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction.
The lot being recalled was distributed around the country between April and May of this year.
Back in January, Mylan was also forced to recall three lots of nizatidine capsules, which is used to treat ulcers and other stomach conditions, after trace amounts of NDMA were found in the medication’s API. This, of course, follows a massive recall of heart medications from several companies in 2018 due to the presence of NDMA, a probable human carcinogen, in the drugs’ APIs.
