AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30

Recall Number: D-0525-2020

Firm: AVKARE Inc.

Classification: Class II

Status: Terminated

Report Date: 20191204

Initiation Date: 20191114

Termination Date: 20211027

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

AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30