# FDA recall D-892-2013

> **American Health Packaging** · Class III · drug recall initiated 2013-02-04.

## Product

buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01

## Reason for recall

Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-892-2013
- **Recalling firm:** American Health Packaging
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-02-04
- **Report date:** 2013-08-21
- **Termination date:** 2013-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-892-2013

## Citation

> AI Analytics. FDA recall D-892-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-892-2013. Source: US FDA. Licensed CC0.

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