PlainRecalls
FDA Drug Moderate Class II Completed

Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.

Reported: November 13, 2019 Initiated: October 1, 2019 #D-0178-2020

Product Description

Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) 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?
Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) 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-0178-2020.