Cardinal Health Recalls Hydrocortisone Cream Due to Temperature Excursions
Cardinal Health Inc. is recalling 143 tubes of Hydrocortisone 1% cream due to intermittent temperature excursions during storage.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a CGMP deviation regarding storage conditions, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Cardinal Health Inc. is recalling 143 tubes of Hydrocortisone 1% 30gm cream. The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.
The affected product, identified by code KK4912, was distributed in Florida, Georgia, and South Carolina. The source text does not specify the exact dates of distribution or the specific retail locations where the product was sold.
Consumers who possess this product should stop using it and contact Cardinal Health Inc. for instructions on how to return the product or obtain a refund. The recall is classified as FDA Class II, indicating that use of or exposure to the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- HYDROCORTISONE 1% 30gm cream
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Topical Steroid
- Affected units
- 143
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)
- KK4912
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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