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U.S. Department of Health and Human Services

Enforcement Report - Week of January 2, 2013

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Product Detail

Product Description 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
Recall Number D-105-2013
Classification Class II
Code Info bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12
Product Distributed Qty 42010 vials
Reason For Recall Lack of Assurance of Sterility; container closure issues with the bulk batch.

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.
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