Genentech, a member of the Roche Group, of South San Francisco, Calif. recalls
1 recall recorded since 2018, most recently on 18 March 2021. Status and classification are as published by the CPSC.
Recalls1
Ongoing (FDA)0
Terminated or completed0
Class I (FDA)0
Announced Consumer products
- Recall started
- 18 March 2021
- Reason
- The bottles containing the prescription drug can leak due to a fit issue between the press-in bottle adapter and bottleneck. If the bottle is leaking, there is a risk of drug exposure by contact with skin or eyes. Prescription drugs must be in child resistant packaging that prevents children from gaining access to the contents as required by the Poison Prevention Packaging Act (PPPA).
- Remedy
- Consumers should immediately store Evrysdi in a safe location out of reach and sight of children. Consumers should inspect the bottle for any leaking. If it is leaking, contact Genentech for a free replacement. Consumers can continue to use as directed, as the leakage is not anticipated to impact the safety or efficacy of administered medicine. If Evrysdi gets on your skin, wash the area with soap and water. If Evrysdi gets in your eyes, rinse your eyes with water. Genentech is contacting all known purchasers directly.
- Recall number
- 21729
CPSC recall notice
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.