Genentech Recalls Prescription Drug Evrysdi Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Drug Exposure through Eye or Skin Absorption (Recall Alert)
Recall at a glance
- Recall number
- 21-729 (CPSC)
- Recall date
- March 18, 2021
- Brand
- Genentech
- Category
- Other consumer products
- Products
- Evrysdi™ (risdiplam)
- Hazard
- Failure to Meet Child Resistant Packaging Requirements; Risk of Drug Exposure through Eye or Skin Absorption (Recall Alert)
- Hazard type
- Poisoning and toxic substances
- Remedy
- Replace
- Units
- About 14,000
- Made in
- Switzerland
- Last updated by CPSC
- March 18, 2021
What was recalled
This recall involves bottles of the prescription drug Evrysdi, a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older. The recalled 100 mL amber bottles have "Evrysdi (risdiplam) for oral solution," the dosage and "NDC 20242-175-07" on the front of the bottle labels.
Is my product affected?
Compare your product with the details below, including model numbers where listed.
- Evrysdi™ (risdiplam) · About 14,000 units
Photos from the recall notice
Where it was sold
Companies named in the notice: 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.; Genentech, a member of the Roche Group, of South San Francisco, Calif..
Injuries or incidents reported
Genentech has received 26 reports of leaking bottles. No injuries have been reported.
Consumer 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.
Recall history and context
Since 2019 CPSC has recorded 399 recalls in the other consumer products category, 68 recalls of them in the past 12 months.
Frequently asked questions
What was recalled?
Evrysdi™ (risdiplam) (About 14,000 units). This recall involves bottles of the prescription drug Evrysdi, a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older.
Why was it recalled?
CPSC lists the reason as: Failure to Meet Child Resistant Packaging Requirements; Risk of Drug Exposure through Eye or Skin Absorption (Recall Alert).
What should I do if I own one?
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…
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Source: U.S. Consumer Product Safety Commission recall data, shown as published and last updated by CPSC on March 18, 2021. Details can change; the official notice is the authority. If your product may be recalled, stop and read the notice before deciding what to do. Terms and disclaimer.