Cardinal Health Recalls Tremfya Injection Due to Temperature Abuse
Cardinal Health Inc. is voluntarily recalling 48 boxes of Tremfya (guselkumab) Injection due to temperature abuse. The affected product was distributed to Alabama, Louisiana, Mississippi, and Tennessee.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or packaging-only issues.
Plain-English summary
Cardinal Health Inc. has voluntarily recalled 48 boxes of Tremfya (guselkumab) Injection, 100 mg/mL, single-dose prefilled syringes. The recall was initiated on March 9, 2021, and was classified as Class III by the FDA. The reason for the recall is temperature abuse, which may affect the stability of the biologic drug.
The affected product is identified by the lot code KESOY.AI with an expiration date of 04/2022. The product was distributed to Alabama, Louisiana, Mississippi, and Tennessee. Tremfya is a prescription-only medication manufactured by Janssen Biotech, Inc. and distributed by Cardinal Health Inc.
This recall is classified as Class III, which indicates that the violation is not likely to cause adverse health consequences. The recall status is currently terminated. Patients and healthcare providers should check their inventory for the specific lot code and expiration date listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations.
The recalled product
- Product
- TREMFYA (GUSELKUMAB)
- Brand
- TREMFYA
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Biologic
- Hazard
- Affected units
- 48
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- KESOY.AI Exp. 04/2022
Distribution
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