D-0649-2020 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
- 624 bottes
Product Description
Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.
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 # 1905225VN, exp. date Apr-2021 1905226VD, exp. date Apr-2021 1906295UN, exp. date May-2021 1906296UN, exp. date May-2021 1906297UN, exp. date May-2021 1906298UD, exp. date May-2021