# FDA recall D-0610-2016

> **Amerisource Health Services** · Class II · drug recall initiated 2016-01-18.

## Product

Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217.

## Reason for recall

Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0610-2016
- **Recalling firm:** Amerisource Health Services
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-01-18
- **Report date:** 2016-02-03
- **Termination date:** 2017-01-11

- **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-0610-2016

## Citation

> AI Analytics. FDA recall D-0610-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0610-2016. Source: US FDA. Licensed CC0.

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