Cardinal Health Recalls Proctofoam Aerosol Due to Temperature Excursions
Cardinal Health is recalling 834 containers of Proctofoam HC aerosol due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
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, but the source text does not report any illnesses or injuries. The hazard is a theoretical risk of reduced efficacy or stability due to temperature excursions, fitting the 'voluntary precautionary recalls' or 'low-risk contamination' criteria for a Moderate score.
Plain-English summary
Cardinal Health Inc. is recalling 834 aerosol containers of Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol. The recall was initiated due to CGMP deviations involving intermittent exposure to temperature excursions during storage.
The affected product is identified by NDC 0037-6822-10 and code 33119. It was distributed in Florida, Georgia, and South Carolina.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- PROCTOFOAM (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE)
- Brand
- PROCTOFOAM
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Topical Prescription
- Affected units
- 834
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)
- 33119
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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