Why it was recalled
Lack of Assurance of Sterility; container closure issues with the bulk batch.
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
Lot numbers, UPCs & expiration codes
bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12
Where it was sold
No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-105-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 5, 2012
- FDA report date
- Jan 2, 2013
- Quantity
- 42010 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- F. Hoffmann-LaRoche Ltd.
Original FDA data
Every field from FDA enforcement report D-105-2013, exactly as published.
Show all FDA fields
- City
- Basel
- Status
- Terminated
- Country
- Switzerland
- Event ID
- 63656
- Address
- Grenzacherstrasse 124
- Code information
- bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12
- Report date
- Jan 2, 2013
- Product type
- Drugs
- Recall number
- D-105-2013
- Classification
- Class II
- Recalling firm
- F. Hoffmann-LaRoche Ltd.
- Product quantity
- 42010 vials
- Termination date
- Aug 29, 2013
- Reason for recall
- Lack of Assurance of Sterility; container closure issues with the bulk batch.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.
- Recall initiation date
- Sep 5, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 21, 2012