FDA-Drug2019-07-31Class II
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ
Ascend Laboratories LLC
Hazard
Failed Dissolution Specifications
Sold states
Product was shipped to wholesalers throughout the United States.
Affected count
a) 5,472 bottles and b) 5,880 bottles
Manufactured in
339 Jefferson Rd Ste 101, N/A, Parsippany, NJ, United States
Products
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1515-2019Don't want to check this manually?
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