Enoxaparin Sodium Injection Recalled for Labeling Error on Declared Strength
Sanofi-Aventis is recalling Enoxaparin Sodium injections because a single syringe with a different strength was found in a carton labeled 120 mg/0.8 mL.
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 source text identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling 11,474 cartons of Enoxaparin Sodium Injection, 120 mg/0.8 mL, pre-filled syringes. The recall is due to a labeling error where a single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL.
The affected product is identified by Lot # 7S572 and an expiration date of 04/2019. The product was distributed nationwide. 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 patients should check their inventory for this specific lot number and expiration date. If the product is found, it should be returned to the distributor or the manufacturer for credit.
The recalled product
- Product
- ENOXAPARIN SODIUM (ENOXAPARIN SODIUM)
- Brand
- ENOXAPARIN SODIUM
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Category
- Drug — Injection
- Hazard
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 #: 7S572
- Exp. 04/2019
Distribution
Distributed nationwide across the United States.
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