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 68462-7…

Recall date

December 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0350-2019

FDA classification

Class II

Brand / firm

Glenmark Pharmaceuticals Inc., USA

Sold / distributed

Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.

Why it was recalled

Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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