Recalls / Class II
Class IID-0538-2020
Product
Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7
- Affected lot / code info
- all lots
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm
- Firm
- Sanofi-Aventis U.S. LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 55 Corporate Dr, Bridgewater, New Jersey 08807-1265
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-10-22
- FDA classified
- 2019-12-01
- Posted by FDA
- 2019-12-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0538-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.