Drug 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.
D-1023-2018
Product summary
- Firm
- PFIZER
- Event
- Event 80399
- Status
- Terminated
- Classification
- Class II
- Quantity
- 234,680 vials
- Official record key
drug-enforcement:D-1023-2018
Official wording
Reason: Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
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.
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Microbial contamination
Microbial Contamination