| Product name |
EvrysdiTM (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. |
| Problem |
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). |
| Distribution |
Select specialty pharmacies nationwide as a prescribed medicine. The price of the medication varies based on health insurance terms and other factors. |
| Company |
Genentech 800-334-0290; web site www.Evrysdi.com |
| Dates sold |
August 2020 through the present |
| Date posted |
03/18/2021 |
| Additional information |
For additional information, visit the U.S. Consumer Product Safety Commission's news release at https://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 |
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