# FDA recall D-1439-2012

> **Apotex Inc.** · Class II · drug recall initiated 2012-04-30.

## Product

Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9

## Reason for recall

Presence of Particulate Matter:  Lots identified in this recall notification may contain small particulates.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1439-2012
- **Recalling firm:** Apotex Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-04-30
- **Report date:** 2012-08-08
- **Termination date:** 2013-09-19

- **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-1439-2012

## Citation

> AI Analytics. FDA recall D-1439-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1439-2012. Source: US FDA. Licensed CC0.

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