Drug recall D-0357-2021

Class III Terminated reported May 5, 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

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.

Lots and codes

Lot #: B1001B05; B1001B08, Exp. Feb-2022

Recall details

Recalling firm
Genentech Inc, South San Francisco, CA
Quantity
2,627 bottles
Distribution
Distributed Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
April 20, 2021
Terminated
January 18, 2022

Related products