Drug product
5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.
D-0417-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 70642
- Status
- Terminated
- Classification
- Class II
- Quantity
- 94,440 bags
- Official record key
drug-enforcement:D-0417-2015
Official wording
Reason: Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Code information: Lot: 37-042-JT, Exp 1JAN2016
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility