Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

Recall Number: D-0613-2020

Firm: Amneal Pharmaceuticals, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20191218

Initiation Date: 20191122

Termination Date:

Reason for Recall

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

Product Description

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).