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

FDA recall notice · announced May 5, 2021 · Genentech

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

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.

Notes

Distribution: Distributed Nationwide in the USA.
Lot/code information: Lot #: B1001B05; B1001B08, Exp. Feb-2022
Quantity: 2,627 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.