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Friday, March 31, 2023

Warning Eye Drops Recall – Two more eyedrop products have been recalled.

Warning Eye Drops Recall – Two more eyedrop products have been recalled.


Consumers are being warned about two new recalls of eyedrops due to contamination hazards that could cause significant damage and eyesight impairment.

A number of eyes drop brands have recently been recalled by the Food and Drug Administration due to worries that they may spread bacterial infections, which might have disastrous health effects like blindness.

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The announcements come after last month’s recall of eyedrops made in India that were connected to an epidemic of illnesses with antibiotic resistance. At least five additional people had irreversible eyesight loss, and one individual passed away.

The most recent recall is from Pharmedica and Apotex as they announced they are voluntarily removing numerous lots of their medicines from the market, the Food and Drug Administration issued separate recall letters for specific eyedrops marketed by those businesses. According to both businesses, the FDA was consulted before conducting the recalls. There is no evidence that the most recent recalls are connected to the products listed below.

On Friday, Pharmedica announced the recall of two lots of Perfectly Soothing 15% MSM Drops because of issues “that could result in blindness.” To cure eye discomfort, over-the-counter drops are available. Consumers should cease using the drops right away, according to the Phoenix-based business, and return them to the store where they were bought.

Eye drops with artificial tears are available from EzriCare and Delsam Pharma. On February 2, Global Pharma Healthcare recalled all lots of the “Artificial Tears Lubricant Eye Drops” sold under the EzriCare and Delsam Pharma brands because they might have been infected with bacteria.

Global Pharma Healthcare who manufactures the eye drops said in a statement, “To date, there are fifty-five reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection. Risk Statement: Use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.”

Which products are affected?

Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, ½ fl oz (15 ml) bottle are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun. The product is packaged in a bottle with a safety seal and are placed in a carton box Ezricare NDC 79503-0101-15, UPC 3 79503 10115 7; Delsam Pharma’s NDC 72570-121-15, UPC 3 72570 12115 8. It can be identified by the photos below. The product was distributed Nationwide in the USA over the Internet.

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Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.  Complete and submit the report Online: www.fda.gov/medwatch/report.htm1 – Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm2 or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178 This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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