# FDA recall D-599-2013

> **Actavis** · Class III · drug recall initiated 2013-06-03.

## Product

Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide

## Key facts

- **Recall number:** D-599-2013
- **Recalling firm:** Actavis
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-03
- **Report date:** 2013-06-19
- **Termination date:** 2014-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salt Lake City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-599-2013

## Citation

> AI Analytics. FDA recall D-599-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-599-2013. Source: US FDA. Licensed CC0.

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