Genentech Inc recalls Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distribut
Recalled May 5, 2021 · FDA recall D-0357-2021 · Genentech
Hazard
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. · FDA Class III
Units
2,627 bottles
Sold at
Distributed Nationwide in the USA.
Description
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.
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(s)
Genentech Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →