Drug Safety Alerts

Daptomycin for Injection Consumer-Level Recall

7/07/2020

On July 7, 2020, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of Daptomycin for Injection 500 mg/vial NDC # 67457-813-50 manufactured by Mylan. This recall was issued due to the presence of particulate matter found in one single-dose vial. Mylan advises that to date it has not received any reports of adverse events related to this recall.

The presence of particulate matter in this product could be a health hazard or safety risk to patients using it.

This recall affects lot number 7605112 exp. 10/2021. This lot was distributed nationwide to wholesalers and retail pharmacies between April 2020 and May 2020.

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 antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) and staphylococcus aureus bloodstream infections (bacteremia) in adult patients.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, please contact Mylan Customer Relations at 1-800-796-9526 or e-mail customer.service@mylan.com, Monday through Friday from 8 a.m. to 5 p.m. (ET) or visit https://newsroom.mylan.com. You may also call the FDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.