FDA-Drug2025-10-22Class II
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
Hazard
Failed Dissolution Specifications
Sold states
U.S. Nationwide
Manufactured in
135 Us Highway 202 206 Ste 15, Bedminster, NJ, United States
Products
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0020-2026More Ascend Laboratories, LLC recalls
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