Drug product
20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045
D-616-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 61918
- Status
- Terminated
- Classification
- Class II
- Quantity
- 216,396 units
- Official record key
drug-enforcement:D-616-2013
Official wording
Reason: Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Code information: Lot #: a) 09-183-JT, Exp 3/13; b) 01-081-JT, Exp 7/12; c) 07-078-JT, 91-083-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