# FDA recall D-802-2013

> **American Health Packaging** · Class II · drug recall initiated 2012-10-10.

## Product

QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10)  Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01

## Reason for recall

Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time  point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-802-2013
- **Recalling firm:** American Health Packaging
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-10-10
- **Report date:** 2013-07-24
- **Termination date:** 2013-08-21

- **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-802-2013

## Citation

> AI Analytics. FDA recall D-802-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-802-2013. Source: US FDA. Licensed CC0.

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