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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)

Recalled March 18, 2021 · CPSC recall 21729 · Genentech

Recalled prescription drug EvrysdiRecalled prescription drug with press-in bottle adapter
Hazard
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
Replace
Units
About 14,000
Incidents / injuries
Genentech has received 26 reports of leaking bottles. No injuries have been reported.

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.

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. 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.

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.

Product
Evrysdi™ (risdiplam)
Manufacturer(s)
Genentech, a member of the Roche Group, of South San Francisco, Calif.
Retailers
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.
Made in
Switzerland

Source: U.S. Consumer Product Safety Commission. Official recall notice on cpsc.gov →

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) | RecallWatchUSA