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)
USGenentech Recalls Prescription Drug Evrysdi Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Drug Exposure through Eye or Skin Absorption (Recall Alert)
Recalling Firm: Genentech, a member of the Roche Group, of South San Francisco, Calif.
Motivo del Retiro / Peligro
TranslatedThe 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).
Descripción del Producto e Identificación
TranslatedThis 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.
Productos Afectados
TranslatedEvrysdi™ (risdiplam)
Additional Source Details
| Field | Value |
|---|---|
| U R L | https://www.cpsc.gov/Recalls/2021/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 |
| Title | 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) |
| Images › 1 › U R L | https://www.cpsc.gov/s3fs-public/Picture1-1_0.jpg |
| Images › 1 › Caption | Recalled prescription drug Evrysdi |
| Images › 2 › U R L | https://www.cpsc.gov/s3fs-public/Picture2-2_0.jpg |
| Images › 2 › Caption | Recalled prescription drug with press-in bottle adapter |
| Hazards › Name | 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). |
| Injuries › Name | Genentech has received 26 reports of leaking bottles. No injuries have been reported. |
| Products › Name | Evrysdi™ (risdiplam) |
| Products › Number Of Units | About 14,000 |
| Recall I D | 9021 |
| Remedies › Name | 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. |
| Retailers › Name | 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. |
| Recall Date | 2021-03-18T00:00:00 |
| 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. |
| Recall Number | 21729 |
| Manufacturers › Name | Genentech, a member of the Roche Group, of South San Francisco, Calif. |
| Remedy Options › Option | Replace |
| 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. |
| Last Publish Date | 2021-03-18T00:00:00 |
| Manufacturer Countries › Country | Switzerland |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsCheck the model number, serial number, and date stamp on the rating label on the back or underside of the product.
Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (CPSC).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Genentech Recalls Prescription Drug Evrysdi Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Dr...?
Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (CPSC). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableGenentech, a member of the Roche Group, of South San Francisco, Calif.
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🚨 SAFETY ALERT: Genentech, a member of the Roche Group, of South San Francisco, Calif. - 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) Check if your household is affected: https://therecallfile.com/es/recalls/genentech-recalls-prescription-drug-evrysdi-due-to-failure-to-meet-chi/CPSC-21729
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