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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: Brimonidine Tartrate Ophthalmic Solution, 0.15% by Apotex: Recall - Due to Cracks that Have Developed in Some of the Units' Caps of the Bottles
AUDIENCE: Eye care, Patient, Health Professional, Pharmacy
ISSUE: Apotex Corp. is initiating a recall for six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15%. This recall is being initiated out of an abundance of caution due to cracks that have developed in some of the units' caps of brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility and, if so, the possibility of adverse events.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Brimonidine tartrate ophthalmic solution is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
RECOMMENDATIONS:
- Patients should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
- Patients who have received the identified lots or have questions regarding this recall should contact their pharmacy. They should immediately contact their health care provider for medical advice and return the identified lots to Inmar Rx Solutions.
- Patients with questions regarding this recall can contact the company.
- Anyone with an existing inventory of the recalled product should quarantine the recalled lots immediately.
- Wholesalers, Distributors, Warehousing Chains, Mail Order Pharmacy and Long-Term Care Pharmacy should return the recalled product to the place of purchase.
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Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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