Last Updated on October 15, 2024 by The Health Master
Apotex Corp., with the knowledge of the USFDA, is initiating a voluntary recall at the Consumer level for six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% specified below.
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.
Brimonidine Tartrate Ophthalmic Solution is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% can be identified by NDC numbers stated on the carton and label of the product.
The lot number and expiry date are located on the top flap of the carton and to the left side of the product description on the bottle label beside the barcode.
These lots were distributed nationwide in the USA between April 05, 2022 to February 22, 2023.
| Product | Strength | Pack Size | NDC # | UPC Code on Carton | UPC Code on Bottle | Lot # | Expiry Date |
|---|---|---|---|---|---|---|---|
| Brimonidine Tartrate Ophthalmic Solution | 0.15% | 5 mL | 60505-0564-1 | 360505056415 | (01)0(03) 60505056415 | TJ9848 | 02/2024 |
| TJ9849 | |||||||
| TK0258 | 04/2024 | ||||||
| TK5341 | |||||||
| 10 mL | 60505-0564-2 | 360505056422 | (01)0(03) 60505056422 | TK0261 | |||
| 15 mL | 60505-0564-3 | 360505056439 | (01)0(03) 60505056439 | TK0262 |
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA)
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