Apotex Corp. is issuing a voluntary nationwide recall of six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15%. The consumer-level recall was initiated with an abundance of caution after some units of Brimonidine tartrate ophthalmic solution bottles developed cracks on the caps.
Brimonidine Tartrate Ophthalmic Solution is indicated to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. This reduces the potential for vision loss, blindness, or nerve damage. The broken caps could cause sterility issues with the medication leading to adverse side effects.
All six (6) slots of the recalled products have their NDC numbers indicated in the carton and label for identification. The top flap of the carton contains the lot numbers and expiry dates. You can also find the lot numbers and expiry information on the bottle label beside the barcode.
The affected Brimonidine Tartrate Ophthalmic Solution, 0.15% lots were distributed countrywide USA between April 05, 2022, to February 22, 2023. The information about the affected products is indicated in the table below.
| 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 |
Apotex Corp. is notifying its distributors, wholesalers, warehousing chains, and pharmacies about the recall through mail and email and is arranging for the return of the affected lots.
Consumers who have bought the affected lots should contact their pharmacies immediately. Patients should contact their healthcare providers for medical advice and return the affected lots in their possession to Inmar Rx Solutions by calling 1-855-275-1273 between 9:00 am to 5:00 pm EST, Monday thru Friday.
Wholesalers, distributors, warehouse chains, and pharmacies with an inventory of the affected products should quarantine them immediately. They should then arrange for their return to the point purchase.
Any questions about this recall can be directed to Apotex Corp. through their phone number 1-800-706-5575 between 8:30 am to 5:00 pm, EST Monday thru Friday, or email them through this address [email protected].
Consumers who have experienced adverse reactions from this product should contact their healthcare providers immediately.
Adverse reactions or quality issues can be reported to the FDA’s MedWatch Adverse Event Reporting online, by regular mail, or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form
- Fax: Submit by fax to 1-800-FDA-0178
This recall is conducted with the full knowledge of the U.S. Food and Drug Administration
