Fresenius Kabi USA, LLC: 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 6

Is my product affected?

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

• Brand PACLITAXEL

Check against the official notice below — it lists the full affected range.

What happened

Fresenius Kabi USA, LLC has recalled Paclitaxel Injection, USP 300 mg/50 mL vials manufactured for APP Pharmaceuticals, LLC due to missing text on the product package insert. Specifically, text was missing from the "Clinical Studies" and "Specific Adverse Events" sections of the labeling. The recall affects 71,129 vials distributed nationwide in the US and Puerto Rico across ten lots with expiration dates between November 2013 and December 2013.

The affected lot numbers are 871ZA00201, 871ZA00301, 871ZA00302, 871ZA00401, 871ZA00402, 872ZA00101, 872ZA00201, 872ZA00301, 872ZA00401, and 872ZA00501. The source document does not specify a remedy or recommended action for consumers who may have this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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 Quantity: 71,129 vials 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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