Drug product
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
D-0026-2026
Product summary
- Firm
- Endo USA, Inc.
- Event
- Event 97557
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 1,041 cartons
- Official record key
drug-enforcement:D-0026-2026
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Code information: Lot #: 550172301, Exp. Date January 2026
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out of specification