Reported Mar 18, 2021
Genentech Recalls Prescription Drug Evrysdi Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Drug…
Genentech, a member of the Roche Group of South San Francisco, Calif.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
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.
Firm contact: Genentech at 800-334-0290 from 8 a.m. to 8 p.m. ET Monday through Friday or online at www.Evrysdi.com and click on the "leaking bottles safety information" banner on the homepage for more information.
What it looks like
Is this the product you have?
- Evrysdi™ (risdiplam)
- Amount recalled
- About 14,000
Where it was sold
Sold at Select specialty pharmacies nationwide as a prescribed medicine from August 2020 through the present. The price of the medication varies based on health insurance terms and other factors..
Why it was recalled
Stop using this product now
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).
Using this product could cause serious injury, illness or death — stop using it now.
Reports so far: Genentech has received 26 reports of leaking bottles. No injuries have been reported.
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