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-0139-2026
Product summary
- Firm
- Endo USA, Inc.
- Event
- Event 97866
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 6,655 cartons
- Official record key
drug-enforcement:D-0139-2026
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Code information: Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out of specification