Home / Recalls / Sanofi-Aventis U.S. LLC / D-0535-2020

D-0535-2020 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 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8

Reason for Recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution Pattern

Nationwide

Code Information

all lots

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