Recalls / Class II
Class IID-0539-2020
Product
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.
- 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-0539-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.