Cymevene 500 mg Powder for Infusion recall: Sterility Concern
Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden…
Why was Cymevene 500 mg Powder for Infusion recalled?
Lack of Assurance of Sterility; container closure issues with the bulk batch.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12
- Product
- Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden…
- Recalling firm
- F. Hoffmann-LaRoche Ltd.
- Quantity
- 42010 vials
- Distribution
- No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.
- Recall date
- January 2, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)