Drug product
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.
D-0543-2020
Product summary
- Event
- Event 84122
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0543-2020
Official wording
Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Code information: all lots
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
NDMA impurity
-
Manufacturing or process control
CGMP Deviations