Genentech Recalls Evrysdi Oral Solution Due to Defective Bottle Adapters
Genentech is recalling 2,627 bottles of Evrysdi (risdiplam) for oral solution because some have incorrect press-in-bottle-adapters that do not fit co-packed syringes.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The issue is a packaging defect that prevents proper administration but does not involve contamination or direct physical harm.
Plain-English summary
Genentech, Inc. is recalling 2,627 bottles of Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL). The recall affects product with Lot numbers B1001B05 and B1001B08, which have an expiration date of February 2022. The product is distributed nationwide in the USA.
The recall was initiated due to complaints regarding defective press-in-bottle-adapters (PIBA). The incorrect adapters have a female fit instead of a male fit, which prevents them from being used in combination with the co-packed syringes required for administration.
Consumers and healthcare providers should stop using the affected product and contact Genentech or their healthcare provider for further instructions.
The recalled product
- Product
- Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, Inc. NDC:50242-175-05
- Manufacturer
- Genentech Inc
- Category
- Drug — Oral Solution
- Affected units
- 2,627
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: B1001B05
- B1001B08
- Exp. Feb-2022
Distribution
Distributed nationwide across the United States.
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