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2 more eyedrop brands announce unrelated recalls

Earlier recall of artificial tears made in India were linked to serious eye injury. The new recalls are voluntary and no injuries are known

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A sign in front of the Food and Drug Administration building is seen in Silver Spring, Md.

A sign in front of the Food and Drug Administration building is seen on Dec. 10, 2020, in Silver Spring, Md. U.S. health officials are alerting consumers about two more recalls of eyedrops due to contamination risks that could lead to vision problems and serious injury.

Manuel Balce Ceneta, Associated Press

The U.S. Food and Drug Administration has announced the recall of two more eyedrops over fear they could be contaminated — a problem that could lead to eye infection and potentially loss of vision.

Last month, the agency announced the recall of eyedrops manufactured in India that are used to provide artificial tears. The drops were linked to drug-resistant eye infections. According to The Associated Press, “one person died and at least five others had permanent vision loss.”

The FDA said then to stop using EzriCare or Delsam Pharma’s artificial tears “pending further guidance.”

The new recalls are voluntary recalls and are unrelated to those serious injuries. They impact several lots of eyedrops from Pharmedica and Apotex.

Per AP, “Pharmedica on Friday said it is recalling two lots of Purely Soothing 15% MSM Drops due to problems ‘that could result in blindness.’” The drops from the Phoenix-based company are supposed to help with eye irritation and dry eyes. Nearly 2,900 bottles have been recalled.

Per the Pharmedica recall notice, “Pharmedica USA LLC is advising customers to immediately stop using the product and return it to the place of purchase. Wholesalers and retailers should stop distributing/return to Pharmedica USA LLC immediately or confirm that the product has been disposed of with proper verification.”

Apotex is recalling six lots of prescription eyedrops for glaucoma. The issue is not damage to the eye, but cracks in the lids of some of the bottles. They sell as Brimonidine Tartrate Ophthalmic Solution 0.15% and were distributed from April 2022 through February 2023.

Apotex told AP it had not received any reports of injuries related to the recalled eyedrops. In its notice, the company said patients who bought the product dated between those dates should contact their pharmacy and call Inmar Rx Solutions at 1-855-275-1273.

Artificial tear recall

Of the earlier recall, Axios reported: “Global Pharma Healthcare announced in February it was voluntarily recalling lots of its Artificial Tears Lubricant Eye Drops, distributed by EzriCare LLC and Delsam Pharma for potential microbial contamination. It also recalled a lot of artificial eye ointment.”

The Centers for Disease Control and Prevention said then that it was joining the FDA and local health departments to investigate a “multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa.” The announcement said the strain had never before been seen in the United States until the outbreak, which included multiple types of infections, including eye infections. Artificial tears appeared to be a common exposure for many patients, CDC said.