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)

Due to the extraordinary circumstances surrounding COVID-19, some of the remedies identified in recall press releases may not be available at this time. Consumers should check with recalling firms for further details.

It is important to remember that CPSC and recalling firms urge consumers not to use recalled products.

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).

Recall date:

March 18, 2021

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

Read More

Add Comment