# FDA recall D-606-2013

> **Teva Pharmaceuticals USA, Inc.** · Class II · drug recall initiated 2013-05-28.

## Product

Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116

## Reason for recall

Failed Dissolution Specification; during stability testing

## Distribution

Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX.  No government or foreign distribution.

## Key facts

- **Recall number:** D-606-2013
- **Recalling firm:** Teva Pharmaceuticals USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-28
- **Report date:** 2013-06-26
- **Termination date:** 2014-07-23

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-606-2013

## Citation

> AI Analytics. FDA recall D-606-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-606-2013. Source: US FDA. Licensed CC0.

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