# FDA recall D-0093-2023

> **Apotex Corp.** · Class III · drug recall initiated 2022-12-21.

## Product

Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4

## Reason for recall

Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0093-2023
- **Recalling firm:** Apotex Corp.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-12-21
- **Report date:** 2023-01-04
- **Termination date:** 2025-10-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Weston, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0093-2023

## Citation

> AI Analytics. FDA recall D-0093-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0093-2023. Source: US FDA. Licensed CC0.

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