FDA Recall D-0541-2020
Sanofi-Aventis U.S. LLC · Bridgewater, NJ
Class II Ongoing 2396 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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.
Recall record
- Recall number
D-0541-2020- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2019-10-22
- Classified by FDA Center
- 2019-12-01
- FDA published
- 2019-12-11
- Recalling firm
- Sanofi-Aventis U.S. LLC
- Firm location
- Bridgewater, NJ
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.