Drug 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
D-0357-2021
Product summary
- Firm
- Genentech Inc
- Event
- Event 87724
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,627 bottles
- Official record key
drug-enforcement:D-0357-2021
Official wording
Reason: 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.
Code information: Lot #: B1001B05; B1001B08, Exp. Feb-2022
Distribution pattern: Distributed Nationwide in the USA.
Derived failure modes
-
Unknown
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.