Drug product
Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11
D-0095-2019
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 81311
- Status
- Terminated
- Classification
- Class II
- Quantity
- 71,075 vials
- Official record key
drug-enforcement:D-0095-2019
Official wording
Reason: Lack of assurance of sterility: loss of container integrity.
Code information: Lot: 609G047, EXP 10/2018
Distribution pattern: Nationwide in the US and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility