# FDA recall D-1837-2019

> **Jubilant Cadista Pharmaceuticals, Inc.** · Class I · drug recall initiated 2019-07-09.

## Product

Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43

## Reason for recall

Failed dissolution specifications : failed results at the 3-month stability time point.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-1837-2019
- **Recalling firm:** Jubilant Cadista Pharmaceuticals, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-07-09
- **Report date:** 2019-08-07
- **Termination date:** 2021-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salisbury, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1837-2019

## Citation

> AI Analytics. FDA recall D-1837-2019. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-1837-2019. Source: US FDA. Licensed CC0.

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