# FDA recall D-0433-2023

> **Apotex Corp.** · Class II · drug recall initiated 2023-03-01.

## Product

Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2; c) 15 mL dropper bottle, NDC 60505-0564-3, UPC 3 60505 05643 9; Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326

## Reason for recall

Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0433-2023
- **Recalling firm:** Apotex Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2023-03-01
- **Report date:** 2023-03-15

- **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-0433-2023

## Citation

> AI Analytics. FDA recall D-0433-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0433-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*