Hormone Drug Recalled

More than 17,400 cartons of Mimvey™ Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, have been pulled from the US market (https://bit.ly/2kUlrWC).
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Teva Pharmaceuticals USA voluntarily initiated the ongoing, Class II, nationwide recall earlier this month, as reported in the latest US Food and Drug Administration (FDA) Enforcement Report.

The recall was issued due to “Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity,” according to the FDA report.

The impacted product is packaged in cartons containing 3 blister cards of 28 tablets each, and has the following code information: lot number 33809881A, Exp 05/17; lot number 33811151A, Exp 08/17.

The medication is indicated for the treatment of certain menopausal-related symptoms (ie, moderate to severe vasomotor symptoms, moderate to severe vulvar and vaginal atrophy symptoms) and for the prevention of postmenopausal osteoporosis.

The FDA gave the recall a Class II designation on February 16, 2017. A Class II recall is described by the FDA as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”--Meredith Edwards White