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U.S. Department of Health and Human Services

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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