FDA-Drug2021-03-10Class III
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, 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:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Sold states
Distributed Nationwide in the USA
Affected count
10,440 90-count and 224,710 500-count bottles
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, 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-0291-2021Don't want to check this manually?
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