Approximately 100,277 units of Relpax (eletriptan HBr) 40 mg tablets are being recalled due to an artwork error on one side of the outer carton. The packaging incorrectly states that each tablet contains 20 mg of eletriptan, when the tablets actually contain the full 40 mg dose. This recall affects various lots distributed nationwide with expiration dates ranging from October 2020 to November 2021.
The labeling error could lead patients to believe they are taking a lower dose of medication than prescribed, potentially resulting in confusion or improper dosing. While the medication inside the blister pack is the correct 40 mg strength, the conflicting information on the outer packaging presents a risk of medication mismanagement.
Drug recall refund/guidance
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Sources: FDA iRES ยท Raw API Response
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