Hospira Recalls Normosol-M Bags With Incorrect Expiration Date Labeling
Hospira is recalling 10,778 bags of Normosol-M and 5% Dextrose Injection due to an incorrect expiration date printed on the primary container.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error regarding the expiration date.
Plain-English summary
Hospira Inc. is recalling 10,778 bags of Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container. The recall was initiated after a confirmed customer report identified an incorrect expiration date printed on the primary container. The label displayed "01AUG1017" instead of the correct date, "01AUG2017".
The affected product is identified by Lot # 56-853-FW and NDC 0409-7965-09. The recall covers distribution in the United States and Hong Kong. This is a Class III recall, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Healthcare providers and facilities should check their inventory for this specific lot number and expiration date discrepancy. Consumers should not use the product if they have it and should contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 10,778
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 #: 56-853-FW
- Exp 01AUG2017
Distribution
Distributed nationwide across the United States.
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