Glenmark Pharmaceuticals Inc., USA recalls Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-71
Recalled January 16, 2019 · FDA recall D-0350-2019 · Glenmark Pharmaceuticals Inc., USA
Hazard
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator · FDA Class II
Units
96,240 applicators
Sold at
Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.
Description
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
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
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →