Endo USA, Inc.: Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceuti
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Endo USA, Inc.
- Product
- Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91
- Reason / hazard
- Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
- Classification
- Class III
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the United States
- Recall initiated
- 2025-10-10
- Code info
- Lot #: 550172201, Exp. Date JAN-26; 550184801, Exp. Date MAR-26; 550204001, Exp. Date JUL-26
- Product quantity
- 2,035 cartons
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Malvern
- State
- PA
- Country
- United States
- Event id
- 97866
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