Paclitaxel Injection, Solution
FDA Recall NDC 63323-763
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Paclitaxel (NDC 63323-763). A significant event, classified as Class III, was initiated on Nov 08, 2013 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Nov 08, 2013
Dec 04, 2013
71,129 vials
Recall Profile & Regulatory Data
Event ID
66810
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US: Nationwide and Puerto Rico
Termination Date
May 12, 2015
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
Batch or Lot Expiration 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
Affected Packages Involved in this Recall
63323-763-05Product
63323-763-16Product
63323-763-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
