Teva Pharmaceuticals USA recalls Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-…

Recall date

February 2, 2017

Source

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

Recall number

D-0479-2017

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Nationwide in the United States

Why it was recalled

Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.