Why it was recalled
Temperature Abuse
Product description
Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01.
Lot numbers, UPCs & expiration codes
KESOY.AI Exp. 04/2022
Where it was sold
AL, LA, MS, TN
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-0314-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 9, 2021
- FDA report date
- Apr 7, 2021
- Quantity
- 48 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cardinal Health Inc.
Original FDA data
Every field from FDA enforcement report D-0314-2021, exactly as published.
Show all FDA fields
- City
- Dublin
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 87489
- Address
- 7000 Cardinal Pl
- Code information
- KESOY.AI Exp. 04/2022
- Postal code
- 43017-1091
- Report date
- Apr 7, 2021
- Product type
- Drugs
- Recall number
- D-0314-2021
- Classification
- Class III
- Recalling firm
- Cardinal Health Inc.
- Product quantity
- 48 boxes
- Termination date
- Nov 4, 2021
- Reason for recall
- Temperature Abuse
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01.
- Distribution pattern
- AL, LA, MS, TN
- Recall initiation date
- Mar 9, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 29, 2021