PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323...
FDA Recall #D-016-2014 — Class III — November 8, 2013
Product Description
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
Reason for Recall
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Recalling Firm
Fresenius Kabi USA, LLC — Lake Zurich, IL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
71,129 vials
Distribution
US: Nationwide and Puerto Rico
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated