# FDA recall D-0585-2016

> **Mayne Pharma Usa** · Class II · drug recall initiated 2016-01-05.

## Product

Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505

## Reason for recall

Lack of Assurance of Sterility: Failed preservative effectiveness test

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0585-2016
- **Recalling firm:** Mayne Pharma Usa
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-01-05
- **Report date:** 2016-01-27
- **Termination date:** 2017-01-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greenville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0585-2016

## Citation

> AI Analytics. FDA recall D-0585-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0585-2016. Source: US FDA. Licensed CC0.

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