FDA Drug recall 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, I…
- FDA Drug
- Class III
- terminated
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class III recall of Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, I… by Genentech, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0357-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-04-20 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Genentech |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot #: B1001B05; B1001B08, Exp. Feb-2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0357-2021%22
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