Prescription Drug Febuxostat Recalled Due to Manufacturing Practice Violations
Amerisource Health Services LLC is recalling approximately 1,932 cartons of Febuxostat (40 mg tablets) nationwide due to deviations from current good manufacturing practices. The firm initiated the recall voluntarily on January 25, 2024.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II, firm-initiated voluntary recall with no reported illnesses or injuries. CGMP deviations relate to manufacturing standards and quality control, making this a precautionary recall with theoretical rather than confirmed harm.
Plain-English summary
The recall affects approximately 1,932 cartons of Febuxostat 40 mg tablets distributed nationwide. The affected product is identified by lot numbers 1015033 (expiration 06/30/2025) and 1016409 (expiration 08/31/2025), distributed by American Health Packaging in Columbus, Ohio.
The U.S. Food and Drug Administration classified this as a Class II recall due to current good manufacturing practice (CGMP) deviations at Amerisource Health Services LLC, the recalling firm. CGMP deviations indicate violations of manufacturing standards and quality control procedures required for pharmaceutical production.
Patients who have received affected cartons should consult with their pharmacy or healthcare provider regarding their medication. The recall was initiated voluntarily by the firm on January 25, 2024, and was classified by the FDA on February 6, 2024.
The recalled product
- Product
- FEBUXOSTAT (FEBUXOSTAT)
- Brand
- FEBUXOSTAT
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Hazard
- cgmp-deviation
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 (4)
- Lot # 1015033
- exp. 06/30/2025
- 1016409
- exp. 08/31/2025
Distribution
Distributed nationwide across the United States.
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