Glenmark Pharmaceuticals Inc., USA recalls Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manu
Recalled June 19, 2019 · FDA recall D-1340-2019 · Glenmark Pharmaceuticals Inc., USA
Hazard
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly. · FDA Class II
Units
31,656 boxes
Sold at
U.S.A. Nationwide
Description
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Product
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
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →