FDA-Drug2025-10-22Class III
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
Endo USA, Inc.
Hazard
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Sold states
Nationwide within the United States
Affected count
1,041 cartons
Manufactured in
9 Great Valley Pkwy, Malvern, PA, United States
Products
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0026-2026Don't want to check this manually?
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