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.
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
Lot numbers, UPCs & expiration codes
Lot #: B1001B05; B1001B08, Exp. Feb-2022
Where it was sold
Distributed Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0357-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 20, 2021
- FDA report date
- May 5, 2021
- Quantity
- 2,627 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Genentech Inc
Original FDA data
Every field from FDA enforcement report D-0357-2021, exactly as published.
Show all FDA fields
- City
- South San Francisco
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 87724
- Address
- 1 Dna Way
- Code information
- Lot #: B1001B05; B1001B08, Exp. Feb-2022
- Postal code
- 94080-4918
- Report date
- May 5, 2021
- Product type
- Drugs
- Recall number
- D-0357-2021
- Classification
- Class III
- Recalling firm
- Genentech Inc
- Product quantity
- 2,627 bottles
- Termination date
- Jan 18, 2022
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed Nationwide in the USA.
- Recall initiation date
- Apr 20, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 29, 2021