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)
Recall 21729 · Mar 18, 2021 · Genentech
14,000
units affected
14,000
units affected
Facts
- Recall number
- 21729
- Date
- Mar 18, 2021
- Company
- Genentech
- Units affected
- 14,000
- Product
- Evrysdi™ (risdiplam)
- Remedy
- Replacement
- Hazard
- Poisoning
The product
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.
What can happen
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).
The fix
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 and where it was sold
- Incidents
- 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.
Related pages
Questions and answers
What should I do with the recalled evrysdi™ (risdiplam)?
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.
What is the 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.
A recall means the maker found a safety problem and offers a free fix; it does not mean every unit has the problem. Units affected are as reported by the company. Popular models sell more and so have more recalls and complaints. Official public data; texts are shortened. Contact the company named above for the remedy.