Drug recall D-1682-2012
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 for recall
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.
Lots and codes
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
Recall details
- Recalling firm
- Hospira Inc., Lake Forest, IL
- Quantity
- 131,264 vials
- Distribution
- Nationwide, including Puerto Rico and Guam. Product was also distributed internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand and Vietnam
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 27, 2012
- Terminated
- December 15, 2016
Related products
- Paclitaxel – drug information
- NDC 61703-342 Paclitaxel · Paclitaxel 6 mg/mL · Hospira, Inc.
- NDC 61703-015 Paclitaxel · Paclitaxel 6 mg/mL · Hospira, Inc.