# FDA recall D-1693-2012

> **Actavis** · Class II · drug recall initiated 2012-07-11.

## Product

Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc.

## Reason for recall

Subpotent; some patches may not contain fentanyl gel

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1693-2012
- **Recalling firm:** Actavis
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-07-11
- **Report date:** 2012-10-03
- **Termination date:** 2013-04-10

- **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-1693-2012

## Citation

> AI Analytics. FDA recall D-1693-2012. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1693-2012. Source: US FDA. Licensed CC0.

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