Drug recall D-0648-2020

Class II Terminated reported Jan 15, 2020

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.

Reason for recall

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Lots and codes

Batch # 1905227UE, exp. date Apr-2021 1905228UE, exp. date Apr-2021

Recall details

Recalling firm
Appco Pharma LLC, Piscataway, NJ
Quantity
1,632 bottes
Distribution
Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
Type
Voluntary: Firm initiated
Recall initiated
January 7, 2020
Terminated
April 24, 2020