Home / Recalls / Sanofi-Aventis U.S. LLC / D-0541-2020

D-0541-2020 Class II Ongoing

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

Recall Details

Product Type
Drugs
Report Date
December 11, 2019
Initiation Date
October 22, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.

Reason for Recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution Pattern

Nationwide

Code Information

all lots

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  • D-0544-2020 Class II — Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Ch (October 22, 2019)