FDA-Drug2019-11-06Class II
Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.
Glenmark Pharmaceuticals Inc., USA
Hazard
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Sold states
Nationwide in the USA
Affected count
216,840 cartons
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0156-2020Don't want to check this manually?
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