September 2012 FDA Recall Drug by F. Hoffmann-laroche Ltd.
D-105-2013 - Lack of Assurance of Sterility; container closure issues with the bulk batch.

This Class II drug recall was voluntarily initiated by F. Hoffmann-laroche Ltd. on September 5, 2012 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; container closure issues with the bulk batch.. The product was distributed in No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea. and the recall is currently terminated.

Recall Number: D-105-2013

Reason for Recall
Lack of Assurance of Sterility; container closure issues with the bulk batch.
Initiated
09-05-2012
Reported
01-02-2013
Quantity
42010 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63656
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
F. Hoffmann-LaRoche Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-29-2013
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12