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

Recalled March 28, 2018 · FDA recall D-0620-2018 · Teva Pharmaceuticals USA

Hazard

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

Units

640,486 vaginal inserts

Sold at

Distributed within the United States and Puerto Rico.

Description

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

Product

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.

Manufacturer(s)

Teva Pharmaceuticals USA

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →