Recalls / Class III
Class IIID-0357-2021
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
- Affected lot / code info
- Lot #: B1001B05; B1001B08, Exp. Feb-2022
Why it was recalled
Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
Recalling firm
- Firm
- Genentech Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Dna Way, N/A, South San Francisco, California 94080-4918
Distribution
- Quantity
- 2,627 bottles
- Distribution pattern
- Distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2021-04-20
- FDA classified
- 2021-04-29
- Posted by FDA
- 2021-05-05
- Terminated
- 2022-01-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0357-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.