Status
Terminated
Drug Enforcement D-915-2013
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Classification
Class II
Report Date
August 28, 2013
Termination Date
May 12, 2015
Product Information
- 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.
- Product quantity
- 23,672 vials
- Reason for recall
- Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Fresenius Kabi USA LLC (FK USA)
- Address
-
1501 E Woodfield Rd, Suite 300 East
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-915-2013
- Event ID
- 64102
- Recall initiation date
- January 22, 2013
- Center classification date
- August 21, 2013
- Code info
- Lot #: 872CZ00101, Exp 12/13
- More code info
- —