FDA Drug recall D-1682-2012
Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent
- FDA Drug
- Class II
- terminated
- Published 2012-09-26
On 2012-09-26 the FDA classified a Class II recall of Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent by Hospira, citing the affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1682-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-27 |
| Published | 2012-09-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; N DC 61703-342-50
Reason
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Identifiers
| ndc | 61703-342-09 |
|---|---|
| ndc | 61703-342-22 |
| ndc | 61703-342-50 |
| ndc | 61703-015-04 |
| code_info | lot numbers Y096865AA, exp AUG 2013; Y106865AA, exp AUG 2013; Y116865AA, exp AUG 2013; Y126865AA, exp SEP 2013; Y136865…lot numbers Y096865AA, exp AUG 2013; Y106865AA, exp AUG 2013; Y116865AA, exp AUG 2013; Y126865AA, exp SEP 2013; Y136865AA, exp SEP 2013; Y146865AA, exp SEP 2013; Y156865AA, exp OCT 2013; Y166865AA, exp NOV 2013; Y176865AA, exp NOV 2013; and Y186865AA, exp DEC 2013 |
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-1682-2012%22
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