# FDA recall D-0350-2019

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2018-12-26.

## Product

Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ

## Reason for recall

Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator

## Distribution

Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.

## Key facts

- **Recall number:** D-0350-2019
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-12-26
- **Report date:** 2019-01-16
- **Termination date:** 2020-10-06

- **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-0350-2019

## Citation

> AI Analytics. FDA recall D-0350-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0350-2019. Source: US FDA. Licensed CC0.

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