FDA-Drug2025-11-05Class III

Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91

Endo USA, Inc.
Hazard

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Sold states
Nationwide within the United States
Affected count
1,866 cartons
Manufactured in
9 Great Valley Pkwy, N/A, Malvern, PA, United States
Products
Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0140-2026

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