(RightWing.org) – The US Food and Drug Administration (FDA) has been busy this year, issuing 39 recalls, market withdrawals, and safety alerts as of the end of February. The federal health agency recently issued an urgent notice regarding a popular eye product used as a lubricant.
On February 21, the FDA warned healthcare professionals and consumers not to purchase an artificial eye ointment manufactured by Global Pharma Healthcare and distributed nationwide by Delsam Pharma. Two days later, the company issued a voluntary recall on the product, and, as is customary, the FDA posted the notice on its website.
The accompanying announcement explained that Global Pharma recalled the product “due to possible microbial contamination,” leakage, and other unspecified compromises of the eye ointment.
A #drug manufacturer has recalled yet another over-the-counter #EyeProduct in the United States amid an outbreak of a rare, antibiotic-resistant #bacterial outbreak that was initially linked to eye drops and artificial tears. https://t.co/EtsR6pJR5V
— Epoch Health (@EpochHealth1) February 24, 2023
The product comes in a 3.5-gram tube bearing the label Delsam Pharma’s Artificial Eye Ointment and is sold as a sterile over-the-counter product. The voluntary recall involves all products from “Batch No. H29,” as indicated below the UPC (3 72570 012235 3) on the products’ exterior package. Likewise, the National Drug Code (NDC) designation is 72570-122-35.
Global Pharma Healthcare urged consumers to contact their doctor or healthcare provider if they experienced any issues that could be related to using the ointment.
Anyone with questions about the recall can contact Delsam Pharma by email at [email protected] or by phone at 1-866-826-1306.
People who want to submit information regarding adverse reactions or quality issues with the ointment can complete and submit a form found on the FDA website here. Alternatively, they can call 1-800-FDA-1088 to request a form and post the pre-addressed document in the US Mail or fax it to 1-800-FDA-0178.
Of additional concern, this situation is the second voluntary notice issued by Global Pharma Healthcare in less than a month for “potential microbial contamination.” On February 2, the company recalled all of its Artificial Tears Lubricant Eye Drops distributed by Delsam Pharma and EzriCare, LLC.
The products are sold in a bottle packaged in a carton box bearing Delsam Pharma’s NDC 72570-121-15 or Ezricare’s NDC 79503-0101-15. At the time of the recall, 55 reports of “adverse events” had been reported, including permanent loss of vision, eye infections, and even one death from a bloodstream infection.
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