Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.

Recall Number: D-0176-2020

Firm: Dr. Reddy's Laboratories, Inc.

Classification: Class II

Status: Completed

Report Date: 20191113

Initiation Date: 20191001

Termination Date:

Reason for Recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Product Description

Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.