# FDA recall D-1340-2019

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2019-06-03.

## 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 for recall

Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-1340-2019
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-06-03
- **Report date:** 2019-06-19
- **Termination date:** 2022-05-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1340-2019

## Citation

> AI Analytics. FDA recall D-1340-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1340-2019. Source: US FDA. Licensed CC0.

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