FDA recall D-1340-2019

Glenmark Pharmaceuticals Inc., USA · Class II · drug

Product

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

Reason for recall

Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.

Distribution

U.S.A. Nationwide

Key facts

Status: Terminated
Initiation date: 2019-06-03
Report date: 2019-06-19
Termination date: 2022-05-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1340-2019