Mylan Recalls One Lot Of Daptomycin For Injection

(RTTNews) - Generic and specialty pharma company Mylan N.V. said its U.S.-based business Mylan Institutional LLC recalled one lot of bacterial infection antibiotic Daptomycin in the form of injection for the potential presence of particulate matter, according to the U.S. Food and Drug Administration or FDA.

The particulate matter was found in one single-dose vial manufactured by Mylan Laboratories Limited's Specialty Formulation Facility.

Mylan Institutional has recalled lot no. 7605112 of Daptomycin for Injection, 500 mg/vial, with expiry date of October 2021, packaged in 20 mL vial. This lot was distributed across the U.S. directly to wholesalers and retail pharmacies between April 2020 and May 2020.

The company is yet to receive any adverse reports after using the recalled product.

The company warned that the intravenous administration of a solution containing visible particulates could lead to serious adverse events including, but not limited to, local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism.

Daptomycin for injection is an injectable lipopeptide antibiotic used to treat systemic and life-threatening bacterial infections of the skin and underlying tissues, and infections that have entered the bloodstream in adult patients. It is used in cases of complicated infections, including vancomycin-resistant Enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA) or "super bug" infections.

In January, Mylan Pharmaceuticals, another U.S.-based business of Mylan N.V., had recalled three lots of ulcer medication Nizatidine Capsules, USP, of 150mg and 300mg strengths of 30 and 60 count bottles for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA).