Class III
Terminated
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
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- November 8, 2013
- Posted
- December 4, 2013
- Recall Number
- D-016-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 71,129 vials
- Firm Location
- Lake Zurich, IL, United States
Reason for Recall
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Distribution
US: Nationwide and Puerto Rico
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
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