D-1340-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2019
- Initiation Date
- June 3, 2019
- Termination Date
- May 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,656 boxes
Product Description
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 Pattern
U.S.A. Nationwide
Code Information
Lot#: 20180516, Exp 4/30/2020