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
Reported: May 5, 2021 Initiated: April 20, 2021 #D-0357-2021
Product Description
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.
Details
- Recalling Firm
- Genentech Inc
- Units Affected
- 2,627 bottles
- Distribution
- Distributed Nationwide in the USA.
- Location
- South San Francisco, CA
Frequently Asked Questions
What product 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. Recalled by Genentech Inc. Units affected: 2,627 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 5, 2021. Severity: Low. Recall number: D-0357-2021.
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