D-0314-2021 Class III Terminated
FDA drug recall D-0314-2021 was initiated by Cardinal Health Inc. on March 9, 2021 and is designated Class III. Reason for recall: Temperature Abuse The recall status is terminated (terminated November 4, 2021). Affected quantity: 48 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- April 7, 2021
- Initiation Date
- March 9, 2021
- Termination Date
- November 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 boxes
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.
Reason for Recall
Temperature Abuse
Distribution Pattern
AL, LA, MS, TN
Code Information
KESOY.AI Exp. 04/2022