Reported Aug 28, 2013 · Terminated
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP…
Fresenius Kabi USA LLC (FK USA)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA LLC (FK USA) · 1501 E Woodfield Rd · Schaumburg, IL · 60173-6052
Is this the product you have?
- IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only
- Manufactured forAPP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7
- Lot codes and dates
Lot #: 872CZ00101Exp 12/13
- Amount recalled
- 23,672 vials
Where it was sold
- Nationwide
Why it was recalled
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
This product could cause temporary or reversible health problems — stop using it.
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