Drug product
Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
D-0648-2020
Product summary
- Firm
- Appco Pharma LLC
- Event
- Event 84610
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,632 bottes
- Official record key
drug-enforcement:D-0648-2020
Official wording
Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Code information: Batch # 1905227UE, exp. date Apr-2021 1905228UE, exp. date Apr-2021
Distribution pattern: Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
Derived failure modes
-
Foreign material or chemical contamination
Impurity N-nitrosodimethylamine (NDMA
-
Manufacturing or process control
CGMP Deviations