FDA-Drug2018-02-07Class III
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05
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) 34,125; b) 3,540 bottles
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0418-2018Don't want to check this manually?
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