top of page
Amit Gupta RPh, Pharm.D, CCP

Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection

If your email program has trouble displaying this email, view it as a web page.


Mylan N.V. External Link Disclaimer  (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured by Mylan Laboratories Limited’s Specialty Formulation Facility. To date, Mylan has not received any reports of adverse events related to this recall. 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.

U.S. Food and Drug Administration 10903 New Hampshire Avenue, Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Privacy Policy | www.fda.gov Manage Preferences or Unsubscribe from this List | Unsubscribe from all Email Lists



10 views0 comments

Recent Posts

See All

Comments


bottom of page