FDA-Drug2019-11-13Class II

Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC

Dr. Reddy's Laboratories, Inc.
Hazard

CGMP Deviations: Presence of NDMA impurity detected in product.

Sold states
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Affected count
N/A
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0175-2020

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