Drug product
DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
D-0526-2020
Product summary
- Event
- Event 84218
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 69,696 bottles
- Official record key
drug-enforcement:D-0526-2020
Official wording
Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Code information: Lot # NBSB19001DA3; Exp FEB 2021
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations