Enoxaparin Sodium recall: Labeling Error
Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10
Why was Enoxaparin Sodium recalled?
Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 7S572, Exp. 04/2019
- Product
- Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10
- Recalling firm
- Sanofi-Aventis U.S. LLC
- Quantity
- 11,474 cartons of 10 syringes per carton
- Distribution
- Distributed nationwide.
- Recall date
- January 17, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)