Teva Pharmaceuticals USA recalls Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC…

Recall date

March 19, 2018

Source

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

Recall number

D-0620-2018

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Distributed within the United States and Puerto Rico.

Why it was recalled

Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.

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

What was recalled

Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wales, PA 19454.