FDA-Drug2018-02-07Class III

Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05

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
a) 28,941 and b) 2,928 bottles
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0419-2018

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