Class II
Completed
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
- Company
- Apotex Corp.
- Recall Initiated
- March 1, 2023
- Posted
- March 15, 2023
- Recall Number
- D-0433-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 67,056 bottles
- Firm Location
- Weston, FL, United States
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.
Distribution
Nationwide in the USA
Lot / 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
More recalls by Apotex Corp.
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only,...
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Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toront...
Jul 2, 2025 · Class II
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ont...
Jun 11, 2025 · Class II
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