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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Category
- Drug — Injectable
- 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.
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