Ascend Laboratories LLC recalls Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx
Recalled July 31, 2019 · FDA recall D-1515-2019 · Ascend Laboratories
Hazard
Failed Dissolution Specifications · FDA Class II
Units
a) 5,472 bottles and b) 5,880 bottles
Sold at
Product was shipped to wholesalers throughout the United States.
Description
Failed Dissolution Specifications
Product
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
Manufacturer(s)
Ascend Laboratories LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →