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)
CPSC Recall1 injuries · 2021-03-18 · 21729
Hazards
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).
Recall
Number
21729
Date
2021-03-18
Injuries reported
1
Products
Names
Evrysdi™ (risdiplam)
Remedies
Options
Replace
Companies
Manufacturer(s)
Genentech, a member of the Roche Group, of South San Francisco, Calif.
Retailer(s)
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.
Country of manufacture
Switzerland
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.