Hormone Tablets Recalled

A mislabeling issue has prompted Teva Pharmaceuticals USA to recall 7 lots of Mimvey (estradiol and norethindrone acetate tablets), 1 mg/0.5 mg, according to the February 9, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes the following products, which were manufactured by Barr Laboratories Inc, Pomona, NY, for Teva Pharmaceuticals USA Inc, North Wales, PA, and distributed throughout the United States:

• Mimvey (NDC 0093-5455-28), packaged in cartons of 28 tablets, from lots 100018611 (Exp. 3/22), 100019834 (Exp. 6/22), 100022226 (Exp. 9/22), and 100024574 (Exp. 1/23), and
• Mimvey (NDC 0093-5455-42), packaged in cartons of 28 tablets, from lots 100018610 (Exp. 3/22), 100021521 (Exp. 9/22), and 100024575 (Exp. 1/23).

Teva Pharmaceuticals USA voluntarily initiated the recall January 7, 2022. The FDA designated the recall Class III on February 2, 2022. Under the recall classification, use of the recalled product is not likely to cause harm.

Mimvey is a prescription hormone replacement therapy used by women to help reduce symptoms of menopause.