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.
FDA recall notice · announced March 25, 2015 · Hospira
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Reason for recall
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Notes
Distribution: Nationwide
Lot/code information: Lot: 37-042-JT, Exp 1JAN2016
Quantity: 94,440 bags
Status: Terminated
Products in this recall event:
- 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, Hospi (D-0417-2015)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.