Drug product
Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720
D-0169-2020
Product summary
- Event
- Event 83908
- Status
- Completed
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0169-2020
Official wording
Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Code information: Batch Numbers: All lots within expiry.
Distribution pattern: Product was distributed to major distributors throughout the United States who may have further distributed the product.
Derived failure modes
-
Foreign material or chemical contamination
NDMA impurity
-
Manufacturing or process control
CGMP Deviations