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.
Reason for recall: Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Recall initiated: 20191022
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated