FDA Drug Class III — Least Serious

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

Hazard

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

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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
Brand
Endo USA, Inc.
UPC
Lot #: 550172301, Exp. Date January 2026

Units Affected

1,041 cartons

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