FDA-Drug2019-01-16Class II
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
Hazard
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Sold states
Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.
Affected count
96,240 applicators
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0350-2019More Glenmark Pharmaceuticals Inc., USA recalls
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