FDA-Drug2019-06-19Class II
Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71
Glenmark Pharmaceuticals Inc., USA
Hazard
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Sold states
U.S.A. Nationwide
Affected count
31,656 boxes
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1340-2019Don't want to check this manually?
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