FDA Drug recall D-0433-2023
Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5
- FDA Drug
- Class II
- completed
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5 by Apotex, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0433-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-03-01 |
| Published | 2023-03-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Apotex |
| Distribution | US |
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
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.
Identifiers
| upc | 360505056415 |
|---|---|
| upc | 360505056422 |
| upc | 360505056439 |
| ndc | 60505-0564-1 |
| ndc | 60505-0564-2 |
| ndc | 60505-0564-3 |
| code_info | Lots: a) TJ9848 Exp. 02/2024, TJ9849 Exp. 02/2024, TK0258 Exp. 04/2024, TK5341 Exp. 04/2024; b) TK0261 Exp. 04/2024; c) TK0262 Exp. 04/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0433-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.