Glenmark Pharmaceuticals Inc., USA recalls Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manu…

Recall date

June 3, 2019

Source

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

Recall number

D-1340-2019

FDA classification

Class II

Brand / firm

Glenmark Pharmaceuticals Inc., USA

Sold / distributed

U.S.A. Nationwide

Why it was recalled

Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.

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 box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71