FDA Drug recall D-016-2014
PACLITAXEL INJECTION, USP (semisynthetic)
- FDA Drug
- Class III
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class III recall of PACLITAXEL INJECTION, USP (semisynthetic) by Fresenius Kabi Usa, citing labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-016-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-11-08 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
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
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Identifiers
| ndc | 63323-763-05 |
|---|---|
| ndc | 63323-763-16 |
| ndc | 63323-763-50 |
| code_info | Lot # 871ZA00201, Exp 11/13 Lot # 871ZA00301, Exp 11/13 Lot # 871ZA00302, Exp 11/13 Lot # 871ZA00401, Exp 11/13…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 history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-016-2014%22
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