Drug product
Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8
D-0536-2020
Product summary
- Event
- Event 84122
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0536-2020
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