FDA DrugsClass II
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx On...
Published: March 25, 2026Recall ID: D-0407-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.
Additional Source Details
| Field | Value |
|---|---|
| City | Weston |
| State | FL |
| Openfda › Unii › 1 | 4S9CL2DY2H |
| Openfda › Unii › 2 | P8Y54F701R |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui | 861635 |
| Openfda › Spl id | afc08ce8-3d89-644d-abdc-61a96ad5d107 |
| Openfda › Brand name | BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION |
| Openfda › Spl set id | 268c3f6b-8798-7987-3b8c-7b7f560af5d7 |
| Openfda › Package ndc › 1 | 60505-0589-1 |
| Openfda › Package ndc › 2 | 60505-0589-2 |
| Openfda › Package ndc › 3 | 60505-0589-3 |
| Openfda › Product ndc | 60505-0589 |
| Openfda › Generic name | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name › 1 | BRIMONIDINE TARTRATE |
| Openfda › Substance name › 2 | TIMOLOL MALEATE |
| Openfda › Manufacturer name | Apotex Corp. |
| Openfda › Application number | ANDA091442 |
| Openfda › Is original packager | true |
| Event id | 98536 |
| Address 1 | 2400 N Commerce Pkwy Ste 400 |
| Address 2 | N/A |
| Code info | Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027 |
| Postal code | 33326-3253 |
| Report date | 20260325 |
| Product type | Drugs |
| Product quantity | 107,136 vials |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260305 |
| Initial firm notification | Letter |
| Center classification date | 20260327 |
Overview
- Recalling FirmApotex Corp.
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide