U.S. Officials Issue Recall For 2 Eye Products

(PatriotWise.com) — The Food and Drug Administration has issued a recall of potentially damaging eye drops. The drops could potentially cause vision problems or other serious injuries to the eye and were distributed by Pharmedica and Apotex. The products being recalled are Purely Soothing 15% MSM Drops, which Pharmedica said “could result in blindness.” The company, based in Phoenix, Arizona, said consumers should immediately stop using the merchandise and return it to the store where it was purchased.

Apotex is withdrawing a product used to treat glaucoma. Brimonidine Tartrate Ophthalmic Solution 0.15% is being recalled due to cracks on the bottle top. The product was manufactured in Canada and the company has reported no injuries.

The recall comes only a month after Food and Drug Administration and the Centers for Disease Control and Prevention advised consumers not to use EzriCare Artificial Tears, which they said was potentially contaminated and linked to an outbreak of Pseudomonas aeruginosa, which had caused one death. The recall notice for this product said, “Use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.”

The Food and Drug Administration (FDA) recalls more than 4,000 products per year. These range from drugs, used by animals or humans, to radiation-emitting devices or cosmetics. It is the responsibility of the manufacturing company to raise the alarm about a product and the FDA is not authorized to force them to recall, it can only make recommendations. It may however have the legal power to force product withdrawal or recall if there is a serious risk to health. When the FDA becomes aware of a potential problem, it carries out a hazard assessment as an initial step. It then classifies the product with an assigned Class. This could be Class 1, 2, or 3 – with each number denoting a level of urgency and the potential threat posed by the product.

The agency warns that even when a product is FDA-approved, it does not necessarily mean it is safe.

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