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OAN Staff Abril Elfi
4:55 PM – Monday, December 16, 2024
Thousands of boxes of a Kirkland Signature cold and flu medicine have been recalled ahead of a possible ingredient ban.
The Food and Drug Administration (FDA) has recalled approximately 8,640 boxes of Kirkland Signature Severe Cold & Flu Plus Congestion, a product sold at Costco.
Oral phenylephrine, a key ingredient in the Kirkland product, is facing an FDA ban reportedly due to its ineffectiveness.
Last year, an outside panel of experts unanimously voted against the efficacy of orally administered phenylephrine as a nasal decongestant, stating that no further trials were required to demonstrate otherwise.
However, the recall is not due to phenylephrine, but to certain “quality control” issues.
The medicine is a 168-count twin pack that pairs 112 coated caplets for day and 56 for night use.
According to the FDA, the medication was recalled due to “CGMP deviations,” which means that the product did not meet the quality control standards known as “Current Good Manufacturing Practices”(CGMPs).
The report stated that the product “should have been rejected” in the first place. However, it did not specify what quality measures it defaulted on.
According to the National Institutes of Health’s (NIH) National Library of Medicine, the Kirkland product’s daytime medications are designed to relieve pain and fever, suppress coughing, lubricate the airways, and promote decongestion.
The evening capsules contain antihistamines to relieve throat and nasal symptoms while inducing drowsiness.
The FDA classified the recall as Class II, indicating that “use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The agency advises customers who have purchased the contaminated capsules to discard them or return them to Costco in order to request a refund.
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