Drug product
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count bottles (NDC 0363-0010-62), d.) 200 count bottles (NDC 0363-0010-01) (Walgreens) OTC
D-0170-2020
Product summary
- Event
- Event 83908
- Status
- Completed
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0170-2020
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