Padagis US LLC is recalling 4,944 cartons of Estradiol Gel (0.1%, 0.25 mg/g) because some packets may not be fully sealed. This defect could allow ethanol to escape from the product, potentially affecting how the medication works. The recall involves 30-packet cartons with NDC 45802-0134-30. If you use this topical gel, you should contact your doctor or pharmacist to discuss your treatment and see if you need a replacement.
A defective seal on individual packets can lead to the loss of ethanol, which is a key component of the gel formulation. This loss could change the concentration of the medication, making it less effective than intended for hormone therapy.
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Manufactured by Padagis in Yeruham, Israel.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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