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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 prescription drug Evrysdi
  • Recalled prescription drug with press-in bottle adapter
Name of Product:
Evrysdi™ (risdiplam)
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
Recall Date:
March 18, 2021
Units:

About 14,000

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 Details

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.

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.

Incidents/Injuries:

Genentech has received 26 reports of leaking bottles.  No injuries have been reported.

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.

Manufacturer(s):

Genentech, a member of the Roche Group, of South San Francisco, Calif.

Manufactured In:
Switzerland
Recall number:
21-729
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About the U.S. CPSC
The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risks of injury or death associated with the use of thousands of types of consumer products. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $1 trillion annually. CPSC’s work to ensure the safety of consumer products has contributed to a decline in the rate of deaths and injuries associated with consumer products over the past 40 years. Federal law bars any person from selling products subject to a publicly announced voluntary recall by a manufacturer or a mandatory recall ordered by the Commission.
For lifesaving information:
SaferProducts.gov