Drug recall D-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
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 number Y064457AA, exp OCT 2013 Rest of world lot numbers: list M4457A001, lot number Y054457AB, exp SEP 2013
Recall details
- Recalling firm
- Hospira Inc., Lake Forest, IL
- Quantity
- 34,572 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
- Methotrexate – drug information
- NDC 61703-408 Methotrexate · Methotrexate Sodium 25 mg/mL · Hospira, Inc.
- NDC 61703-350 Methotrexate · Methotrexate Sodium 25 mg/mL · Hospira, Inc.