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

FDA recall notice · announced August 12, 2020 · Mylan Institutional

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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

Notes

Distribution: USA Nationwide
Lot/code information: Lot #: 7605112, Exp 10/2021
Quantity: 18,480 vials
Status: Terminated
Products in this recall event:
- 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 (D-1484-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.