Mimvey 1 mg/0 recalled over labeling errors

Recall date

January 7, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Teva Pharmaceuticals USA recalls Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manuf…

Recall number

D-0522-2022

FDA classification

Class III

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

USA Nationwide

Why it was recalled

Mislabeling

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42