Cardinal Health Recalls Hydrocortisone Acetate Suppositories for Temperature Excursions
Cardinal Health Inc. is recalling Hydrocortisone Acetate 30mg suppositories due to intermittent exposure to temperature excursions during storage.
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: The recall is classified as FDA Class II, and the hazard involves storage temperature deviations which are typically considered lower risk or theoretical without reported injuries, fitting the Moderate criteria for low-risk contamination or precautionary measures.
Plain-English summary
Cardinal Health Inc. is recalling Hydrocortisone Acetate 30mg suppositories (NDC 0574-7093-12) due to deviations from Current Good Manufacturing Practices (CGMP). The specific issue identified is intermittent exposure to temperature excursions during storage.
The affected product is a prescription-only medication distributed by Perrigo in Allegan, Michigan. The recall involves 95 suppositories. Distribution was limited to Florida, Georgia, and South Carolina.
Consumers and healthcare providers with this product should stop using it and contact their pharmacist or healthcare provider for guidance on replacement or disposal. The recall is classified as Class II by the FDA.
The recalled product
- Product
- HYDROCORTISONE ACETATE (HYDROCORTISONE ACETATE)
- Brand
- HYDROCORTISONE ACETATE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 95
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)
- 433202
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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