Altaire Pharmaceuticals, Inc. announced in early July that it was recalling certain brands of eyedrops being sold at Wal-Mart, Walgreens, and other pharmacy retailers across the United States. In FDA announcements related to the recall, it is being described as a “precautionary measure,” with no reports of adverse health effects to consumers at this time. However, the manufacturer, Altaire, discovered information which led to concerns regarding the sufficiency of quality assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance, which, it notes, can be quite serious: “Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.”
The first recall was put out early in the month, but subsequent recalls (involving more retailers and brands of eyedrops) have continued throughout the month.
Earlier this month, we discussed a recall targeting popular hot dog and hamburger buns, which were found to contain small bits of plastic that posed a choking hazard. We discussed the law surrounding defective products, and examined how flaws in the initial design of a product, issues in the way a product is sold or marketed, or flaws which occur during the production or packaging process can lead to defects which may give rise to a claim against the entity responsible for designing, manufacturing, and/or selling the product. Both the bakery goods and eye drop recalls issued this month highlight just how critical the manufacturing and packaging process is and how much potential harm consumers might face if errors occur during these stages.
Another thing both of these cases have in common is that they involve a voluntary recall. A voluntary recall is when a company becomes aware of an issue that might affect a product on the shelf and takes the appropriate steps to remove the product from retailers and inform consumers who may have already purchased the product as to what the potential issue may be, and how to identify recalled products (the product name, retailer, expiration date). The FDA itself can also conduct a recall of a product.
Consumers have the ability to inform the organization about concerns related to any product regulated by the FDA. The FDA’s Safety Reporting Portal allows you to submit concerns related to premarket or marketed human drug and biologics, human or animal foods, animal drugs, tobacco products, and dietary supplements. FDA’s MedWatch allows you to report adverse reactions related to human medical problems.
If you are concerned that you may have purchased recalled eyedrops, visit the FDA’s recall page for more information on the brands and retailers involved. Further, consumers are advised that they should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the eyedrops.
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