# FDA recall D-0487-2015

> **Apotex Inc.** · Class III · drug recall initiated 2015-02-12.

## Product

Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326.  Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.

## Reason for recall

CGMP Deviations: Product excipient was not re-tested at the appropriate date.

## Distribution

U.S. Nationwide.

## Key facts

- **Recall number:** D-0487-2015
- **Recalling firm:** Apotex Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-02-12
- **Report date:** 2015-04-22
- **Termination date:** 2016-12-30

- **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-0487-2015

## Citation

> AI Analytics. FDA recall D-0487-2015. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0487-2015. Source: US FDA. Licensed CC0.

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