Enforcement Report - Week of January 2, 2013
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Event Detail
| Event ID | 63656 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | F. Hoffmann-LaRoche Ltd. |
| City | Basel |
| State | |
| Country | CH |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-05 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom | bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12 | Class II | Lack of Assurance of Sterility; container closure issues with the bulk batch. | 42010 vials | D-105-2013 |
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