# FDA recall D-248-2013

> **Actavis South Atlantic LLC** · Class III · drug recall initiated 2013-03-22.

## Product

buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL  33325; Packaged by: American Health Packaging, Columbus, OH  43217; NDC 67767-142-30.

## Reason for recall

Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-248-2013
- **Recalling firm:** Actavis South Atlantic LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-03-22
- **Report date:** 2013-04-24
- **Termination date:** 2014-05-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunrise, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-248-2013

## Citation

> AI Analytics. FDA recall D-248-2013. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-248-2013. Source: US FDA. Licensed CC0.

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