Drug product
5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
D-0215-2019
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 81199
- Status
- Terminated
- Classification
- Class II
- Quantity
- 372,912 bags
- Official record key
drug-enforcement:D-0215-2019
Official wording
Reason: Lack of Assurance of Sterility; bags have the potential to leak
Code information: Lots: a) 84-017-JT Exp. December 01, 2019; b) 84-012-JT Exp. June 01, 2019
Distribution pattern: Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility