Roche Recalls Cymevene Powder for Infusion Due to Sterility Concerns
F. Hoffmann-LaRoche Ltd. is recalling Cymevene 500 mg Powder for Infusion due to container closure issues that compromise sterility assurance. No product was distributed in the USA.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the loss of sterility assurance in an infusion product is a significant safety hazard.
Plain-English summary
F. Hoffmann-LaRoche Ltd. is recalling Cymevene 500 mg Powder for Infusion (ganciclovir), 50 mg/mL, 10 mL vials. The recall is due to container closure issues with the bulk batch that result in a lack of assurance of sterility.
The affected product includes bulk lot N0019 and finished product lots N0019B01 through N0019B12. The source text states that no product was distributed in the USA. Bulk product was distributed to Switzerland, with further distribution in Europe, Scandinavia, and Korea.
Consumers and healthcare providers in the United States are not affected by this recall. Those in affected regions should contact their healthcare provider or the manufacturer for instructions on how to handle the recalled product.
The recalled product
- 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
- Manufacturer
- F. Hoffmann-LaRoche Ltd.
- Category
- Drug — Antiviral
- Affected units
- 42,010
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- bulk lot N0019
Distribution
Distribution scope not specified by the agency.
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