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Evrysdi™ (risdiplam)

CPSC Recall #21-729 — March 18, 2021

Recall Summary

Recall Number21-729
Recall DateMarch 18, 2021
Remedy TypeReplace
Units AffectedAbout 14,000
ManufacturerGenentech, a member of the Roche Group, of South San Francisco, Calif.
Manufactured InSwitzerland

Where It Was Sold

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.

Product

Evrysdi™ (risdiplam)

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.

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).

Incidents & Injuries

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

Remedy Instructions

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.

What Should You Do?

Stop using this product immediately. Contact the manufacturer for a Replace at no charge. If you experienced an injury, report it at SaferProducts.gov.

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Frequently Asked Questions

Follow the consumer action instructions in the recall notice above. Most recalls require you to stop using the product and contact the manufacturer directly — either by calling the toll-free number listed in the official CPSC notice or by visiting the manufacturer's website. You generally do not need a receipt or original packaging to claim a remedy. The manufacturer is legally required to provide the remedy (Replace) at no cost to you.

Yes. If you were injured by a defective consumer product — whether recalled or not — you may have grounds for a product liability claim against the manufacturer and potentially the retailer. A recall notice can serve as evidence that the manufacturer was aware of the defect. Injuries that may support a claim include burns, lacerations, fractures, electric shock, choking incidents, and chemical exposure. Most product liability attorneys work on a contingency fee basis, meaning you pay nothing unless you win. Consult an attorney promptly, as statutes of limitation vary by state.

In most cases, no. CPSC-coordinated recall remedies are designed to be accessible without proof of purchase. Manufacturers typically ask consumers to self-certify ownership and may ask for photos of the product or its serial number. Some manufacturers request that you mail in a portion of the product (such as a cut cord or removed component) as proof of disposal. Check the specific remedy instructions for this recall for exact requirements. If you registered your product at the time of purchase, the process is usually even simpler.

If the original manufacturer has gone out of business, the recall remedy may no longer be available through them. In this case, contact CPSC directly at 1-800-638-2772 or cpsc.gov for guidance. If the brand was acquired by another company, the acquiring company may have assumed recall obligations. In some cases where a remedy is unavailable, CPSC advises consumers to safely dispose of the product. If you were injured by the product of a defunct company, consult a product liability attorney — parent companies, distributors, and retailers may still bear liability in some circumstances.

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