Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.

FDA recall notice · announced August 8, 2018 · Pfizer

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.

Reason for recall

Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.

Notes

Distribution: Nationwide in the USA and Puerto Rico.
Lot/code information: Lot #: 712453A, Exp 1-Nov-18; 771803A, Exp 1-May-19; 792103A, Exp 1-Jul-19; 800903A, Exp 1-Aug-19; 810853A, Exp 1-Sep-19; 841703A, 841753A, Exp 1-Dec-19; 850553A, Exp 1-Jan-20.
Quantity: 234,680 vials
Status: Terminated
Products in this recall event:
- Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01. (D-1023-2018)

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