D-0156-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 6, 2019
- Initiation Date
- October 22, 2019
- Termination Date
- June 7, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 216,840 cartons
Product Description
Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.
Reason for Recall
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Distribution Pattern
Nationwide in the USA
Code Information
Batch numbers: a) 20180514, 20180544, Apr-2020; 20180545, 20180546, 20180588, May-2020; 20190003, Jun-2020; b) 20180515, 20180543, Apr-2020; 20180587, May-2020