2 Companies Initiate Voluntarily Recall for Eye Drops


The companies, Apotex and Pharmedica, are doing this action due to concerns of sterility of the products.

Earlier this month, 2 companies that manufacture eye drop products initiated voluntary recalls due to concerns of sterility. No reports of ophthalmic injuries have been reported and both companies are doing said action out of an abundance of caution.

Both recalls are being conducted with the knowledge of the FDA.

Apotex Recall
Florida-based Apotex Corp., initiated a recall on March 1 for six lots of their Brimonidine Tartrate Ophthalmic Solution, 0.15% specified below. The company said the recall was being initiated out of an abundance of caution due to cracks that have developed in some of the units caps of the bottles. There is a possibility the broken cap may impact sterility and if so, the possibility of adverse events.

The product is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

The affected product is the following:

Apotex said it was 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.

For more information on the recall, people can go to the FDA website here.

Pharmedica Recall
Arizona-based Pharmedica USA has recalled its Purely Soothing, 15% MSM Drops.The eye drops are used as an anti-inflammatory aimed to assist with symptoms of ocular irritation and/or swelling. The product is packaged in white, cylindrical HDPE bottles. The eye drops (LOT#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9) have eye dropper caps and white lids. The product can be identified by the labels below.

For more information on the recall, people can go to the FDA website here.

Separate Eye Drop Issue
Last month, it was reported by CDC thatEzriCare Artificial Tears had been associated with multidrug resistant (MDR) Pseudomonas aeruginosa. The federal agency was investigating a multistate cluster of Verona Integron‐mediated Metallo‐β‐lactamase (VIM)‐ and Guiana‐Extended Spectrum‐β‐Lactamase (GES) producing carbapenem resistant Pseudomonas aeruginosa (VIM‐GES-CRPA) associated with multiple different infection types, including eye infections.

At that time, the CDC said there were 50 cases across 11 states, and some of the patient outcomes included permanent vision loss resulting from ocular infection, hospitalization, and death of one patient with bloodstream infection. CDC warned people to refrain from using the brand.

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