Drug product
5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045
D-614-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 61918
- Status
- Terminated
- Classification
- Class II
- Quantity
- 267,288 units
- Official record key
drug-enforcement:D-614-2013
Official wording
Reason: Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Code information: Lot #: a) 01-201-JT, Exp 7/12; b) Lot 91-054-JT, Exp 7/12
Distribution pattern: Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility