Drug 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
D-1340-2019
Product summary
- Event
- Event 83019
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31,656 boxes
- Official record key
drug-enforcement:D-1340-2019
Official wording
Reason: Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Code information: Lot#: 20180516, Exp 4/30/2020
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Unknown
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.