Drug product
Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62
D-1425-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 68631
- Status
- Terminated
- Classification
- Class II
- Quantity
- 142,152 bags
- Official record key
drug-enforcement:D-1425-2014
Official wording
Reason: Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
Code information: Lot # 34-811-KL, 36-106-KL, 36-114-KL; Exp. 12/15; 36-101-KL, Exp. 12/15; 37-202-KL, Exp. 1/16; 38-302-KL, Exp. 2/16; 38-305-KL, Exp. 2/16
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility