FDA Drug recall D-1340-2019
Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmar…
- FDA Drug
- Class II
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class II recall of Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmar… by Glenmark Pharmaceuticals Usa, citing defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1340-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-03 |
| Published | 2019-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
Reason
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Identifiers
| ndc | 68462-711-71 |
|---|---|
| ndc | 68462-711-88 |
| code_info | Lot#: 20180516, Exp 4/30/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1340-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.