FDA recall D-105-2013

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

Reason for recall

Lack of Assurance of Sterility; container closure issues with the bulk batch.

Distribution

No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.

Key facts

Status

Terminated

Initiation date

2012-09-05

Report date

2013-01-02

Termination date

2013-08-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Basel, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-105-2013