Drug product
5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
D-0885-2018
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 80213
- Status
- Terminated
- Classification
- Class II
- Quantity
- 267288 bags
- Official record key
drug-enforcement:D-0885-2018
Official wording
Reason: Lack of assurance of sterility: Bags have potential to leak.
Code information: Lot #: 86-033-JT, Exp 08/01/2019
Distribution pattern: Nationwide and Canada
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility