# FDA recall D-0009-2016

> **Apotex Inc.** · Class II · drug recall initiated 2015-08-25.

## Product

Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.

## Reason for recall

Lack of Assurance of Sterility: Failed preservative effectiveness testing

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0009-2016
- **Recalling firm:** Apotex Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-08-25
- **Report date:** 2015-10-21
- **Termination date:** 2022-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Toronto, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0009-2016

## Citation

> AI Analytics. FDA recall D-0009-2016. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0009-2016. Source: US FDA. Licensed CC0.

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