Reported May 5, 2021 · Terminated
Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only,…
Genentech Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Genentech Inc · 1 Dna Way · South San Francisco, CA · 94080-4918
Is this the product you have?
- Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only
- Distributed byGenentech, Inc
- NDC50242-175-05
- Lot codes and dates
Lot #: B1001B05B1001B08Exp. Feb-2022
- Amount recalled
- 2,627 bottles
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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