Brimonidine Tartrate Ophthalmic Solution 0 — Class II drug recall D-0433-2023
Completed recall by Apotex Corp., reported 2023-03-15, distributed nationwide. Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmi
| Recall number | D-0433-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2023-03-01 |
| Classified | 2023-03-03 |
| Reported by FDA | 2023-03-15 |
| Distributed | Nationwide (US) |
| Quantity | 67,056 bottles |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00360505056415, 00360505056422, 00360505056439 |
| NDC | 60505-0564, 60505-0564-01, 60505-0564-02, 60505-0564-03 |
| Expiration dates | 2024-02, 2024-04 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0433-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.