Apotex Corp. Brimonidine Tartrate Ophthalmic Solution

Apotex Corp., with the knowledge of the US FDA, 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.

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.

Apotex Corp. is notifying all impacted direct accounts (Wholesalers, Distributors, Warehousing Chains, Mail Order Pharmacy and Long-Term Care Pharmacy) of this voluntary recall via email and mail (FedEx Standard Overnight) and is arranging for return of all recalled 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 by contacting at the phone number provided in the Consumer Contact box below.

Wholesalers, Distributors, Warehousing Chains, Mail Order Pharmacy and Long-Term Care Pharmacy should return the recalled product to the place of purchase. Anyone with an existing inventory of the recalled product should quarantine the recalled lots immediately. 

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA