FDA-Drug2021-06-23Class III

Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.

Dr. Reddy's Laboratories, Inc.
Hazard

Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities

Sold states
Nationwide within the United States
Affected count
5984 bottles
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0629-2021

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