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.
Reason for recall: Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Recall initiated: 20180319
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated