Recalls / Class II
Class IID-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
- Brand name
- Paclitaxel
- Generic name
- Paclitaxel
- Active ingredient
- Paclitaxel
- Route
- Intravenous
- NDCs
- 61703-015, 61703-342
- FDA application
- ANDA076131
- Affected lot / code info
- 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
Why it was recalled
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.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 131,264 vials
- Distribution pattern
- 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
Timeline
- Recall initiated
- 2012-06-27
- FDA classified
- 2012-09-19
- Posted by FDA
- 2012-09-26
- Terminated
- 2016-12-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1682-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.