# FDA recall D-0661-2020

> **AVKARE Inc.** · Class II · drug recall initiated 2020-01-07.

## Product

Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.

## Reason for recall

Failed Impurities/Degradation Specifications: High out of specification results for related compounds.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0661-2020
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-07
- **Report date:** 2020-01-22
- **Termination date:** 2021-07-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0661-2020

## Citation

> AI Analytics. FDA recall D-0661-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0661-2020. Source: US FDA. Licensed CC0.

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