FDA recall D-0176-2020

Dr. Reddy's Laboratories, Inc. · Class II · drug

Product

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

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution

Product was distributed to major distributors throughout the United States who may have further distributed the product.

Key facts

Status
Completed
Initiation date
2019-10-01
Report date
2019-11-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0176-2020