Drug product
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.
D-0891-2018
Product summary
- Event
- Event 80254
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14089 vials
- Official record key
drug-enforcement:D-0891-2018
Official wording
Reason: Superpotent Drug: High out of specification assay value results for potency.
Code information: Lot #: 17034-2, 17035-2, 17036-2; Exp. 08/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Superpotent