D-016-2014 Class III Terminated
FDA drug recall D-016-2014 was initiated by Fresenius Kabi USA, LLC on Nov 8, 2013 and is designated Class III. Reason for recall: Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections. The recall status is terminated (terminated May 12, 2015). Affected quantity: 71,129 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 4, 2013
- Initiation Date
- Nov 8, 2013
- Termination Date
- May 12, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71,129 vials
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.
Distribution Pattern
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-016-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026