FDAFDA · Food and drugs·Recall number D-0357-2021
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
Published May 5, 2021 · Recall initiated: April 20, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Genentech Inc
- Distributor
- Distributed Nationwide in the USA.
- Lot
- Lot #: B1001B05; B1001B08, Exp. Feb-2022
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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