Drug product
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.
D-0156-2020
Product summary
- Event
- Event 84071
- Status
- Terminated
- Classification
- Class II
- Quantity
- 216,840 cartons
- Official record key
drug-enforcement:D-0156-2020
Official wording
Reason: Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
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
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.