Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC

Recall Number: D-0171-2020

Firm: Dr. Reddy's Laboratories, Inc.

Classification: Class II

Status: Completed

Report Date: 20191113

Initiation Date: 20191001

Termination Date:

CGMP Deviations: Presence of NDMA impurity detected in product.

Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC