Evrysdi™ (risdiplam)
Genentech, a member of the Roche Group, of South San Francisco, Calif.
Summary
CPSC recall: Evrysdi™ (risdiplam). By Genentech, a member of the Roche Group, of South San Francisco, Calif.. 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 (P
Details
Source
CPSC Consumer Product Recall
External ID
9021
Action Date
2021-03-18
Status
Recalled
Category
consumer_product
Product Description
This recall involves bottles of the prescription drug Evrysdi, a prescription medicine used to treat spinal muscular atr
Context & Analysis
This is a unclassified recall.
This was one of 8 consumer_product recalls issued in the same week, part of 47 consumer_product-related FDA actions this month.
Genentech, a member of the Roche Group, of South San Francisco, Calif. has 2 FDA actions in our database, including 1 recall.
Frequently Asked Questions
What is a FDA recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Genentech, a member of the Roche Group, of South San Francisco, Calif.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Genentech, a member of the Roche Group, of South San Francisco, Calif. have FDA actions?
Genentech, a member of the Roche Group, of South San Francisco, Calif. has 2 FDA actions in our database, including 1 recall and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "9021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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