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.

FDA recall notice · announced August 28, 2013 · Fresenius Kabi Usa Llc (fk Usa)

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Crystallization: Active pharmaceutical ingredient is precipitating in product solution.

Notes

Distribution: Nationwide
Lot/code information: Lot #: 872CZ00101, Exp 12/13
Quantity: 23,672 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.