Recalls / Class II
Class IID-1681-2012
Product
Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-408-41
- Brand name
- Methotrexate
- Generic name
- Methotrexate
- Active ingredient
- Methotrexate Sodium
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDCs
- 61703-350, 61703-408
- FDA application
- NDA011719
- Affected lot / code info
- lot number Y064457AA, exp OCT 2013 Rest of world lot numbers: list M4457A001, lot number Y054457AB, exp SEP 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
- 34,572 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-1681-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.