Cardinal Health Recalls Estradiol Transdermal Systems Due to Temperature Excursions
Cardinal Health Inc. is recalling 72 cartons of Estradiol Transdermal Systems 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 a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 72 cartons of Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly). The product is manufactured for Mylan Pharmaceuticals Inc. and is distributed in Florida, Georgia, and South Carolina.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The affected product has the code 3108206.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- ESTRADIOL (ESTRADIOL)
- Brand
- ESTRADIOL
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Transdermal Patch
- Affected units
- 72
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)
- 3108206
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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