PlainRecalls
FDA Drug Moderate Class II Completed

Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)

Reported: November 13, 2019 Initiated: October 1, 2019 #D-0181-2020

Product Description

Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)

Reason for Recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Details

Units Affected
N/A
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC). Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: N/A.
Why was this product recalled?
CGMP Deviations: Presence of NDMA impurity detected in product.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 13, 2019. Severity: Moderate. Recall number: D-0181-2020.