Noven Recalls Estradiol Transdermal Patches Due to Adhesive Defects
Noven Pharmaceuticals is recalling Estradiol Transdermal Systems because the adhesive may not stick well to the skin.
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 functional defect (poor adhesion) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Noven Pharmaceuticals Inc. is recalling Estradiol Transdermal Systems, a prescription medication used to deliver estradiol to the body. The recall involves 10,872 cartons of the 0.0375 mg/day strength, specifically Lot #88321 with an expiration date of 02/2022. These products were distributed nationwide within the United States.
The recall was initiated because the transdermal patches failed to meet specifications for release rate testing and shear, which relates to the adhesive properties of the patches. As a result, patients may experience patches that do not adhere properly to the skin.
Consumers who have this specific lot of Estradiol Transdermal Systems should stop using them and contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- ESTRADIOL (ESTRADIOL)
- Brand
- ESTRADIOL
- Manufacturer
- Noven Pharmaceuticals Inc
- Category
- Drug — Transdermal Patch
- Affected units
- 10,872
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)
- Lot #: 88321 Exp. 02/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Noven Pharmaceuticals 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.
See all 2 products in this recall →Related recalls
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- ModerateCardinal Health Recalls Estradiol Transdermal Systems Due to Temperature Excursions
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