Drug product
0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045
D-619-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 61918
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,933,936 units
- Official record key
drug-enforcement:D-619-2013
Official wording
Reason: Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Code information: Lot #: a) 11-085-JT, Exp 11/13; b) 06-111-JT, Exp 12/12, c) 93-030-JT, 14-044-JT, Exp 9/12
Distribution pattern: Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility