Enforcement Report - Week of September 26, 2012
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Product Detail
| Product Description | Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-303-46 |
|---|---|
| Recall Number | D-1680-2012 |
| Classification | Class II |
| Code Info | lot numbers Y131994AA, exp AUG 2013; Y141994AA, exp SEP 2013; Y151994AA, exp SEP 2013; Y161994AA, exp NOV 2013; Y171994AA, exp NOV 2013 and Y181994AA, exp NOV 2013 |
| Product Distributed Qty | 210 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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