# FDA recall D-917-2013

> **Actavis South Atlantic LLC** · Class III · drug recall initiated 2013-08-21.

## 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, UPC 3 67767-142-30 6.

## Reason for recall

Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets  (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-917-2013
- **Recalling firm:** Actavis South Atlantic LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-08-21
- **Report date:** 2013-09-04
- **Termination date:** 2014-04-10

- **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-917-2013

## Citation

> AI Analytics. FDA recall D-917-2013. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-917-2013. Source: US FDA. Licensed CC0.

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