D-0648-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 15, 2020
- Initiation Date
- January 7, 2020
- Termination Date
- April 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,632 bottes
Product Description
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.
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Distribution Pattern
Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
Code Information
Batch # 1905227UE, exp. date Apr-2021 1905228UE, exp. date Apr-2021