Mylan announced the voluntary recall of 1 lot of Daptomycin for Injection, 500mg/vial due to the presence of particulate matter found in 1 single-dose vial.
The recalled lot, Daptomycin for injection 500mg/vial; NDC# 67457-813-50; Lot Number 7605112; Expiry Date October 2021, was distributed nationwide to wholesalers and retail pharmacies between April 2020 and May 2020. Daptomycin is indicated for the treatment of susceptible complicated skin and skin structure infections in adults and pediatric patients and Staphylococcus aureus bacteremia in adult patients.
According to Mylan, the administration of the recalled product may lead to “serious adverse events including, but not limited to, local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism.” At this time, the Company has not received any reports of adverse events related to this recall.
The Company is notifying its distributors and consumers regarding the proper return of the recalled product. Consumers/distributors/retailers in possession of the recalled product should discontinue use or further distribution. Any adverse events associated with the recall should be reported to the FDA’s MedWatch program.
For more information regarding this recall contact Mylan Pharmaceuticals by calling (800) 796-9526 or emailing [email protected]