Glenmark Pharmaceuticals Inc., USA recalls Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (
Recalled November 6, 2019 · FDA recall D-0156-2020 · Glenmark Pharmaceuticals Inc., USA
Hazard
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator. · FDA Class II
Units
216,840 cartons
Sold at
Nationwide in the USA
Description
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Product
Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →