FDA-Drug2025-10-22Class II
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Ascend Laboratories, LLC
Hazard
Failed Dissolution Specifications
Sold states
U.S. Nationwide
Affected count
141,984 bottles
Manufactured in
135 Us Highway 202 206 Ste 15, Bedminster, NJ, United States
Products
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) 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-0017-2026Don't want to check this manually?
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