Enforcement Report - Week of September 26, 2012
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Product Detail
| 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 |
|---|---|
| Recall Number | D-1681-2012 |
| Classification | Class II |
| Code Info | lot number Y064457AA, exp OCT 2013 Rest of world lot numbers: list M4457A001, lot number Y054457AB, exp SEP 2013 |
| Product Distributed Qty | 34,572 vials |
| 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. |
Event Detail
| Event Id | 62459 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Hospira Inc. |
| City | Lake Forest |
| State | IL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-27 |
| Initial Firm Notification of Consignee or Public | Letter |
| 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 |
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