# FDA recall D-0156-2020

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2019-10-22.

## 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.

## Reason for recall

Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0156-2020
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-10-22
- **Report date:** 2019-11-06
- **Termination date:** 2021-06-07

- **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-0156-2020

## Citation

> AI Analytics. FDA recall D-0156-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0156-2020. Source: US FDA. Licensed CC0.

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