Class II
Terminated
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
- Recall Initiated
- June 3, 2019
- Posted
- June 19, 2019
- Recall Number
- D-1340-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 31,656 boxes
- Firm Location
- Mahwah, NJ, United States
Reason for Recall
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Distribution
U.S.A. Nationwide
Lot / Code Info
Lot#: 20180516, Exp 4/30/2020
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