FDA-Drug2018-02-07Class III

Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05

Dr. Reddy's Laboratories, Inc.
Hazard

Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

Sold states
Nationwide
Affected count
12,579 bottles
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0420-2018

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