Class II
Ongoing
Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0121-01, 0597-0121-06, 0597-0121-08, 0597-0121-09, 0597-0121-11, 0597-0121-24, 0597-0121-38, 0597-0121-50, 0597-0121-64, 0597-0121-66, 0597-0121-68, 0597-0121-78, 0597-0121-80, 0597-0121-82, 0597-0121-85, 0597-0121-90, 0597-0121-94.
- Company
- Sanofi-Aventis U.S. Llc
- Recall Initiated
- October 22, 2019
- Posted
- December 11, 2019
- Recall Number
- D-0539-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Bridgewater, NJ, United States
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution
Nationwide
Lot / Code Info
all lots
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