Drug product
Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9701-01.
D-66447-002
Product summary
- Event
- Event 66447
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9813 vials
- Official record key
drug-enforcement:D-66447-002
Official wording
Reason: Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Code information: Lot #: AC0026, AC0027, Exp 10/14
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent