FDA-Drug2018-06-27Class III

Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA

Dr. Reddy's Laboratories, Inc.
Hazard

Failed Impurities/Degradation Specifications

Sold states
Nationwide in the USA and Puerto Rico
Affected count
130,081 bottles
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0888-2018

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