FDAFDA · Food and drugs·Recall number D-915-2013
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.
Published August 28, 2013 · Recall initiated: January 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Kabi USA LLC (FK USA)
- Distributor
- Nationwide
- Lot
- Lot #: 872CZ00101, Exp 12/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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