Key Takeaway
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) by Genentech, a member of the Roche Group, of South San Francisco, Calif. was recalled on March 18, 2021. What to 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....
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)
Description
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.
Injuries / Consequence
Genentech has received 26 reports of leaking bottles. No injuries have been reported.
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.
Products Affected
Evrysdi™ (risdiplam)
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Company Information
Genentech, a member of the Roche Group, of South San Francisco, Calif.
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View all 1 recalls by Genentech, a member of the Roche Group, of South San Francisco, Calif. →Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
The listed remedy for this recall is: 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 re...
Where can I find the original recall notice?
This recall was issued by CPSC. You can view the original notice using the link provided above.