PlainRecalls
FDA Drug Critical Class I Terminated

Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50

Reported: August 12, 2020 Initiated: July 7, 2020 #D-1484-2020

Product Description

Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50

Reason for Recall

Presence of Particulate Matter

Details

Recalling Firm
Mylan Institutional LLC
Units Affected
18,480 vials
Distribution
USA Nationwide
Location
Rockford, IL

Frequently Asked Questions

What product was recalled?
Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50. Recalled by Mylan Institutional LLC. Units affected: 18,480 vials.
Why was this product recalled?
Presence of Particulate Matter
Which agency issued this recall?
This recall was issued by the FDA Drug on August 12, 2020. Severity: Critical. Recall number: D-1484-2020.