METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)

FDA recall notice · announced March 27, 2013 · Hospira

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)

Reason for recall

Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.

Notes

Distribution: Nationwide.
Lot/code information: Lot code 12-074-JT Exp 12/13
Quantity: 567,624 bags
Status: Terminated
Products in this recall event:
- METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24) (D-206-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.