Drug product
Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03
D-1852-2019
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 83699
- Status
- Terminated
- Classification
- Class II
- Quantity
- 185,700 vials
- Official record key
drug-enforcement:D-1852-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: W20308, Exp. Dec 1, 2019
Distribution pattern: Nationwide US and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility