# FDA recall D-0069-2018

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2017-10-25.

## Product

Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA.

## Reason for recall

Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.

## Distribution

Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-0069-2018
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-10-25
- **Report date:** 2017-11-08
- **Termination date:** 2018-05-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Wales, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0069-2018

## Citation

> AI Analytics. FDA recall D-0069-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0069-2018. Source: US FDA. Licensed CC0.

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