Product: Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ
Reason for recall: Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Recall initiated: 20181226
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated