D-1681-2012 Class II Terminated
FDA drug recall D-1681-2012 was initiated by Hospira Inc. on Jun 27, 2012 and is designated Class II. 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 recall status is terminated (terminated Dec 15, 2016). Affected quantity: 34,572 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 26, 2012
- Initiation Date
- Jun 27, 2012
- Termination Date
- Dec 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,572 vials
Product Description
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.
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
Code Information
lot number Y064457AA, exp OCT 2013 Rest of world lot numbers: list M4457A001, lot number Y054457AB, exp SEP 2013
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1681-2012
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026