# FDA recall D-0122-2017

> **Par Pharmaceutical, Inc.** · Class III · drug recall initiated 2016-09-27.

## Product

Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By:  Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL  35811

## Reason for recall

Subpotent Drug; Ethinyl Estradiol

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0122-2017
- **Recalling firm:** Par Pharmaceutical, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2016-09-27
- **Report date:** 2016-11-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chestnut Ridge, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0122-2017

## Citation

> AI Analytics. FDA recall D-0122-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0122-2017. Source: US FDA. Licensed CC0.

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