Hospira Recalls Demerol Ampoules Due to Missing Container Labels
Hospira Inc. is recalling 237,850 ampoules of Demerol (meperidine HCL) because the immediate container labels are missing. The recall is nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a packaging/labeling defect without reported injuries.
Plain-English summary
Hospira Inc. is recalling 237,850 ampoules of Demerol, meperidine HCL Injection USP, 25 mg/0.5 mL (50 mg/mL). The product is identified by NDC 0409-1203-01 and Lot 221303A, with an expiration date of October 1, 2014. The recall is being conducted nationwide.
The recall was initiated because the ampoules are missing the immediate container label. This labeling defect prevents the identification of the product on the immediate container.
The U.S. Food and Drug Administration has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for this specific lot and NDC number and stop using the affected ampoules if found.
The recalled product
- Product
- Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC 0409-1203-01, Hospira, Inc., Lake Forest, IL.
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 237,850
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 (2)
- Lot: 221303A
- 1OCT2014
Distribution
Distributed nationwide across the United States.
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