D-0357-2021 Class III Terminated
FDA drug recall D-0357-2021 was initiated by Genentech Inc on Apr 20, 2021 and is designated Class III. 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… The recall status is terminated (terminated Jan 18, 2022). Affected quantity: 2,627 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 5, 2021
- Initiation Date
- Apr 20, 2021
- Termination Date
- Jan 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,627 bottles
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.
Distribution Pattern
Distributed Nationwide in the USA.
Code Information
Lot #: B1001B05; B1001B08, Exp. Feb-2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0357-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026