The Recall Desk
SevereFDA (Drugs)·D-206-2013·Announced 2013-03-27

Hospira Recalls Metronidazole Injection Bags Due to Sterility Concerns

Hospira Inc. is recalling 567,624 bags of Metronidazole Injection due to a potential leak that compromises sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Hospira Inc. is recalling 567,624 bags of METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag (NDC 0409-7811-24). The recall affects Lot code 12-074-JT with an expiration date of 12/13. The product was distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. There is a potential for the solution to leak from the administrative port to the fill tube seal, which may compromise the sterile integrity of the medication.

Healthcare providers and patients should stop using the affected product and contact their pharmacist or the recalling firm for further instructions. The FDA has classified this as a Class II recall.

The recalled product

Product
METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)
Manufacturer
Hospira Inc.
Affected units
567,624

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot code 12-074-JT Exp 12/13

Distribution

Distributed nationwide across the United States.