Recalls / Class II
Class IID-1679-2012
Product
Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-50 (Hospira label), NDC 61703-360-50 (Novoplus label)
- Brand name
- Carboplatin
- Generic name
- Carboplatin
- Active ingredient
- Carboplatin
- Route
- Intravenous
- NDC
- 61703-339
- FDA application
- ANDA076517
- Affected lot / code info
- lot numbers Y061711AA, exp FEB 2013 and Y061711AB, exp FEB 2013 rest of world lots being recalled: list M1685A001, lots numbers Y151686AB, exp MAY 2013 and Y131686AA, exp MAR 2013; list M1723A001, lot number Y121686AF, exp SEP 2013; list M1686ADE1, lot numbers Y121686AA, exp SEP 2013 and Y151686AC, exp NOV 2013; list M1686AFR1, lot numbers Y121686AG, exp SEP 2013 and Y131686AB, exp SEP 2013; list M1714A001, lot number Y121686AC, exp SEP 2013; list M1686ANO3, lot number Y121686AE, exp SEP 2013; list M1686ASE2, lot number Y121686AB, exp SEP 2013
Why it was recalled
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig 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
- 30,582 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-1679-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.