Home / Recalls / Sanofi-Aventis U.S. LLC / D-0153-2018

D-0153-2018 Class III Terminated

Recalled by Sanofi-Aventis U.S. LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
January 17, 2018
Initiation Date
December 5, 2017
Termination Date
October 11, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,474 cartons of 10 syringes per carton

Product Description

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

Reason for Recall

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

Distribution Pattern

Distributed nationwide.

Code Information

Lot #: 7S572, Exp. 04/2019

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  • D-0540-2020 Class II — Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P (October 22, 2019)
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  • D-0537-2020 Class II — Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P (October 22, 2019)
  • D-0535-2020 Class II — Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P (October 22, 2019)
  • D-0539-2020 Class II — Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company (October 22, 2019)
  • D-0541-2020 Class II — Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company (October 22, 2019)