D-915-2013 Class II Terminated
FDA drug recall D-915-2013 was initiated by Fresenius Kabi USA LLC (FK USA) on January 22, 2013 and is designated Class II. Reason for recall: Crystallization: Active pharmaceutical ingredient is precipitating in product solution. The recall status is terminated (terminated May 12, 2015). Affected quantity: 23,672 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 28, 2013
- Initiation Date
- January 22, 2013
- Termination Date
- May 12, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,672 vials
Product Description
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.
Reason for Recall
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Distribution Pattern
Nationwide
Code Information
Lot #: 872CZ00101, Exp 12/13