Drug product
Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC
D-0175-2020
Product summary
- Event
- Event 83908
- Status
- Completed
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0175-2020
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