BRIMONIDINE TARTRATE Recall D-0433-2023
Description: 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
BRIMONIDINE TARTRATE Recall D-0433-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0433-2023 |
| Event ID | 91803 |
| Brand | BRIMONIDINE TARTRATE |
| Generic Name | BRIMONIDINE TARTRATE |
| Manufacturer | BRIMONIDINE TARTRATE |
| Original Package? | 1 |
| Active Substance | BRIMONIDINE TARTRATE |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA |
| Quantity | 67,056 bottles |
| Recall 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. |
| Drug Classification | Class II |
| Drug Code Info | 20230315 |
| Product NDC | 60505-0564 |
| Drug UPC | 360505056415 360505056422 360505056439 |
| Recall Initiation Date | 20230301 |
| Report Date | 20230315 |
| Classification Date | 20230303 |
| Address | 2400 N Commerce Pkwy Ste 400 Weston, FL 33326-3253 United States |
| Recalling Firm | Apotex Corp. |
| Initial Notification | Press Release |
| Unique Ingredient Identifier | 4S9CL2DY2H |
| Drug Application Number | ANDA078479 |
| Structured Product Labeling (SPL ID) | 566ae0f8-fdea-33ec-d315-2d2376805ab1 |
| Structured Product Labeling (SPL Set ID) | 64b21e68-610c-5194-ccb2-9d9f6ff8cda9 |
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