Apotex Corp. and Pharmedica USA have initiated voluntary recalls for consumers to cease use of their eye drop solution products—Brimonidine Tartrate Ophthalmic Solution 0.15% and Purely Soothing 15% MSM Drops, respectively—following reports over non-sterility.
Wait … didn’t we just have a few recalls?
Indeed we did. In January 2023, the CDC advised for the immediate discontinuation of EzriCare Artificial Tears following reports of permanent vision loss in patients across the country (it later issued an update on February 6, 2023).
And in February 2023, the FDA extended that recall to include Delsam Pharma’s Artificial Eye Ointment.
Talk about Apotex’s recall first.
Apotex’s Brimonidine Tartrate Ophthalmic Solution 0.15% is indicated for intraocular pressure (IOP) reduction in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT).
The company is recalling the product due to reports of cracks in six lots of the solution that have developed into some of the units’ caps on the bottles—which could impact sterility and, potentially, cause adverse events (AEs) for consumers.
How about Pharmedica?
Pharmedica’s Purely Soothing 15% MSM Drops are used as an anti-inflammatory to aid with symptoms of ocular irritation and/or swelling.
According to the company, two lots are being recalled due to potential non-sterility—and the risk for eye infections that could lead to blindness.
Any reported adverse reactions?
As of March 1 and March 3, respectively, Apotex and Pharmedica have received no reports of any AEs or illnesses associated with their products.
How do I know if my solution is included in the recall?
Both solutions can be identified via NDC numbers listed on the carton and product labels. The distribution dates of the affected Apotex lots are April 5, 2022 to February 22, 2023. See here for the Apotex lot numbers and here for Pharmedica’s lot numbers.
Both companies have also reached out to wholesalers carrying the solutions and advised they stop distribution and return the affected products to their respective companies.
Who should I contact if I have a recalled product?
Consumers are advised to contact their pharmacies and immediately reach out to their healthcare provider (HCP) for medical advice and to return the products to their place of purchase.
For Apotex, products can be returned to Inmar Rx Solutions (1-855-275-1273) and further questions can be directed to Apotex Corp (1-800-706-5575).
For Pharmedica, consumers can contact the company directly (1-632-698-1752).