Drug recall D-1340-2019

Class II Terminated reported Jun 19, 2019

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.

Lots and codes

Lot#: 20180516, Exp 4/30/2020

Recall details

Recalling firm
Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Quantity
31,656 boxes
Distribution
U.S.A. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
June 3, 2019
Terminated
May 2, 2022

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