Mass Recall of Thousands of Boxes of Kirkland Signature Cold and Flu Medicine – One America News Network
OAN Staff Abril Elfi
4:55 PM – Monday, December 16, 2024
Thousands of boxes of Kirkland Signature cold and flu medicine have been recalled due to potential ingredient issues.
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The Food and Drug Administration (FDA) has issued a recall for approximately 8,640 boxes of Kirkland Signature Severe Cold & Flu Plus Congestion, available at Costco.
Oral phenylephrine, a crucial component of the Kirkland product, is reportedly facing an FDA ban because of its lack of effectiveness.
An external panel of experts voted last year against the effectiveness of orally administered phenylephrine as a nasal decongestant, stating that additional trials were unnecessary to prove its ineffectiveness.
Nonetheless, the recall is not related to phenylephrine, but to specific “quality control” concerns.
The product in question is a 168-count twin pack featuring 112 caplets for daytime use and 56 for nighttime use.
The FDA reported that the recall was due to “CGMP deviations,” indicating that the product failed to adhere to the quality standards known as “Current Good Manufacturing Practices” (CGMPs).
The report noted that the product “should have been rejected” initially, but did not detail the specific quality standards it violated.
According to the National Institutes of Health’s (NIH) National Library of Medicine, the daytime medications in the Kirkland product are intended to alleviate pain and fever, curb coughing, soothe the airways, and assist with decongestion.
The nighttime capsules contain antihistamines designed to relieve throat and nasal discomfort while promoting drowsiness.
The FDA has classified the recall as Class II, suggesting that “use of, or exposure to, a violative product may lead to temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse health consequences is remote.”
The agency recommends that customers who have purchased the affected capsules either discard them or return them to Costco to request a refund.
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