Drug product
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
D-915-2013
Product summary
- Event
- Event 64102
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,672 vials
- Official record key
drug-enforcement:D-915-2013
Official wording
Reason: Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Code information: Lot #: 872CZ00101, Exp 12/13
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.