drugs Class III Updated 2013-12-04

Fresenius Kabi USA, LLC recalls PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6

Recalled Product

PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Manufactured for APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India

Hazard / Issue

Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 871ZA00201, Exp 11/13 Lot # 871ZA00301, Exp 11/13 Lot # 871ZA00302, Exp 11/13 Lot # 871ZA00401, Exp 11/13 Lot # 871ZA00402, Exp 11/13 Lot # 872ZA00101, Exp 12/13 Lot # 872ZA00201, Exp 12/13 Lot # 872ZA00301, Exp 12/13 Lot # 872ZA00401, Exp 12/13 Lot # 872ZA00501, Exp 12/13
View official government recall

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