Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cymevene 500 mg Powder for Infusion Recalled by F. Hoffmann-LaRoche Ltd. Due to Lack of Assurance of Sterility; container closure issues...

Date: September 5, 2012
Company: F. Hoffmann-LaRoche Ltd.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact F. Hoffmann-LaRoche Ltd. directly.

Affected Products

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

Quantity: 42010 vials

Why Was This Recalled?

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

Where Was This Sold?

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

About F. Hoffmann-LaRoche Ltd.

F. Hoffmann-LaRoche Ltd. has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report