Drug product
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,
D-0097-2023
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 91379
- Status
- Completed
- Classification
- Class II
- Quantity
- 62,088 bags
- Official record key
drug-enforcement:D-0097-2023
Official wording
Reason: Lack of assurance of sterility: Bags have the potential to leak.
Code information: Lot: 5935283, Exp. 12/01/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility