FDA Recall of Eye Drops

In February and early March 2023, the US Food and Drug Administration announced the voluntary recall of three ophthalmic products:

• EzriCare Artificial Tears Lubricant Eye Drops, a GlobalPharma product
• Brimonidine Tartrate Ophthalmic Solution (0.15%), an Apotex Corp. product
• Purely Soothing 15% MSM Drops, a Pharmedica USA product

In an August 2023 update, the FDA added two additional types of eye drops to their warning list:

• Dr. Berne’s MSM Drops 5% Solution
• LightEyez MSM Eye Drops - Eye Repair¹

In October 2023, the FDA expanded the list further to include over two dozen over-the-counter eye drop products.² To date, only the EzriCare Artificial Tears have been linked to any injuries.

Global Pharma Healthcare EzriCare Artificial Tears Recall

The EzriCare Artificial Tears recall was issued after affected batches of the product tested positive for contamination with a drug-resistant strain of Pseudomonas aeruginosa, a bacterial pathogen.³

In its recall materials, the FDA focuses on violations of Global Pharma Healthcare’s current good manufacturing practice (CGMP) obligations:

• Lack of appropriate microbial testing,
• Formulation issues linked to the company distributing the product in multi-use bottles without adequate preservatives, and
• Lack of tamper-evident packaging controls.

Cases of Pseudomonas aeruginosa infection related to the use of EzriCare Artificial Tears have been reported in fifteen states: California, Colorado, Connecticut, Florida, Illinois, North Carolina, New Jersey, New Mexico, New York, Pennsylvania, South Dakota, Texas, Utah, Washington, and Wisconsin.³

In 2023, over 55 reports of injuries linked to the use of EzriCare Artificial Tears were reported to the FDA.⁴ Most reports described eye infections, but some reported total vision loss, surgeries required to remove an eye, and death by systemic infection.³

Apotex Corp Brimonidine Tartrate Ophthalmic Solution (0.15%); Alphagan P

Alphagan P is the brand name of Apotex Corp’s Brimonidine Tartrate Ophthalmic Solution (0.15%). Apotex received FDA approval to sell the solution under its brand name Alphagen P in January 2022 to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.⁵

In March 2023, Apotex Corp issued a voluntary recall of six lots of Alphagan P due to potential lack of sterility after bottle caps cracked. No injuries were reported.⁶

Pharmedica USA LLC Purely Soothing 15% MSM Drops Recall

Pharmedica USA LLC Purely Soothing 15% MSM drops were recalled for “non-sterility.” The recall was issued worldwide. To date, no injuries or infections have been reported.⁷

EzriCare Artificial Tears

Some containers of EzriCare artificial tears have been reported to be contaminated with Pseudomonas aeruginosa. The strain of Pseudomonas aeruginosa (VIM-GES-CRPA) is a drug-resistant strain, never reported in the US before this outbreak.

EzriCare Artificial Tears have been linked to several serious infections, three deaths, eight cases of vision loss, and four cases requiring surgical removal of the entire eyeball.

The product has been voluntarily recalled by its maker, Global Pharma Healthcare.

Alphagan P

Cracks on the bottle cap led to a voluntary recall of six lots of Alphagan P. No injuries were reported.

Purely Soothing

“Non-sterility” led to a recall of several lots of Pharmedica USA LLC Purely Soothing 15% MSM Drops. No injuries were reported.

EzriCare: HIGH. Available evidence strongly supports the inference that EzriCare Artificial Tears were contaminated with a strain of bacteria not previously identified in the United States, and that infection with this bacterial strain led to eye infections, systemic infections, vision loss, the need for surgery, and/or death in various patients.

Alphagan P and Purely Soothing: LOW. As no injuries or infections have yet been linked to these recalls, available evidence does not support the inference that the recalled products have in fact caused injuries.