PACLITAXEL INJECTION — Class III drug recall D-016-2014
Terminated recall by Fresenius Kabi USA, LLC, reported 2013-12-04, distributed nationwide. Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" an
| Recall number | D-016-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2013-11-08 |
| Classified | 2013-11-22 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2015-05-12 |
| Distributed | Nationwide (US) |
| Quantity | 71,129 vials |
| Reason classes | labeling |
| NDC | 63323-0763, 63323-0763-05, 63323-0763-16, 63323-0763-50 |
| Lot numbers | 11/13, 12/13, 871ZA00201, 871ZA00301, 871ZA00302, 871ZA00401, 871ZA00402, 872ZA00101, 872ZA00201, 872ZA00301, 872ZA00401, 872ZA00501 |
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 for recall
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-016-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.