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Apotex Corp has announced the voluntary recall of 6 lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% due to cracks found in the unit caps of the solution bottles.
Brimonidine Tartrate Ophthalmic Solution, an alpha-adrenergic receptor agonist, is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The recalled lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% were distributed nationwide between April 5, 2022 and February 22, 2023. According to the Company, the broken caps may affect the sterility of the product and lead to possible adverse events.
The following Brimonidine Tartrate Ophthalmic Solution, 0.15% products are being recalled out of an abundance of caution:
- Pack size 5mL; NDC # 60505-0564-1; Lot # TJ9848 and TJ9849; Expiration Date 02/2024.
- Pack size 5mL; NDC # 60505-0564-1; Lot # TK0258 and TK5341; Expiration Date 04/2024.
- Pack size 10mL; NDC # 60505-0564-2; Lot # TK0261; Expiration Date 04/2024.
- Pack size 15mL; NDC # 60505-0564-3; Lot # TK0262; Expiration Date 04/2024.
Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.
Reference
Apotex Corp. issues voluntary nationwide recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% due to cracks that have developed in some of the units caps of the bottles. News release. Apotex Corp. March 1, 2023. Accessed March 2, 2023. https://prnmedia.prnewswire.com/news-releases/apotex-corp-issues-voluntary-nationwide-recall-of-brimonidine-tartrate-ophthalmic-solution-0-15-due-to-cracks-that-have-developed-in-some-of-the-units-caps-of-the-bottles-883134720.html.
