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.

Recall Number: D-0648-2020

Firm: Appco Pharma LLC

Classification: Class II

Status: Terminated

Report Date: 20200115

Initiation Date: 20200107

Termination Date: 20200424

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

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.