Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02
Reported: December 11, 2019 Initiated: October 22, 2019 #D-0542-2020
Product Description
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Details
- Recalling Firm
- Sanofi-Aventis U.S. LLC
- Distribution
- Nationwide
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02. Recalled by Sanofi-Aventis U.S. LLC.
Why was this product recalled? ▼
CGMP Deviations: Presence of NDMA impurity detected in product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 11, 2019. Severity: Moderate. Recall number: D-0542-2020.
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