Genentech Inc recalls Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distribu…

Recall date

April 20, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0357-2021

FDA classification

Class III

Brand / firm

Genentech Inc

Sold / distributed

Distributed Nationwide in the USA.

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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