FDA-Drug2013-08-28Class II
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.
Fresenius Kabi USA LLC (FK USA)
Hazard
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Sold states
Nationwide
Affected count
23,672 vials
Manufactured in
1501 E Woodfield Rd, Suite 300 East, Schaumburg, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-915-2013Don't want to check this manually?
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