RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32

Recall Number: D-0632-2020

Firm: Granules India Limited

Classification: Class II

Status: Ongoing

Report Date: 20200108

Initiation Date: 20191213

Termination Date:

Reason for Recall

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

Product Description

RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32