FDA-Drug2021-05-05Class III
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
Genentech Inc
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.
Sold states
Distributed Nationwide in the USA.
Affected count
2,627 bottles
Manufactured in
1 Dna Way, N/A, South San Francisco, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0357-2021Don't want to check this manually?
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