Padagis US LLC is recalling 43,238 cartons of Evamist (estradiol transdermal spray), 1.53 mg per spray, because the product failed to meet spray uniformity requirements during stability testing. Testing at the 18-month mark showed that the amount of medication delivered in each spray may not be consistent with required standards. The recall affects 0.27 fl oz (8.1 mL) metered-dose pumps labeled with NDC 0574-2067-27 and lot number SCDR.
Failed spray uniformity means the device might deliver an inconsistent dose of estradiol, which could potentially lead to patients receiving slightly more or less medication than prescribed. The risk to consumers is considered low, and there have been no reported injuries related to this issue.
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Manufactured by DPT Laboratories, Ltd San Antonio, TX; Manufactured for: Perrigo, Minneapolis, MN.
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Sources: FDA iRES · Raw API Response
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