Multi event Drug Recall Enforcement Report Class II voluntary initiated by Apotex Corp., originally initiated on 05-28-2025 for the product Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4 The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0495-2025 | 05-28-2025 | 07-02-2025 | Class II | 105,456 Bottles | Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4 | Lack of Assurance of Sterility | Ongoing |
| D-0496-2025 | 05-28-2025 | 07-02-2025 | Class II | 6,288 Bottles | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3 | Lack of Assurance of Sterility | Ongoing |
| D-0494-2025 | 05-28-2025 | 07-02-2025 | Class II | 87,840 bottles | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2 | Lack of Assurance of Sterility | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 60505-0578 | Azelastine Hydrochloride | Azelastine Hydrochloride | Solution/ Drops | Intraocular | Apotex Corp. | Human Prescription Drug |
| 60505-0589 | Brimonidine Tartrate/timolol Maleate Ophthalmic Solution | Brimonidine Tartrate And Timolol Maleate | Solution | Ophthalmic | Apotex Corp. | Human Prescription Drug |
| 60505-1003 | Ketorolac Tromethamine | Ketorolac Tromethamine | Solution/ Drops | Ophthalmic | Apotex Corp. | Human Prescription Drug |
