A Costco-brand Cold and flu medicine Thousands have been pulled from the shelves.
Kirkland Severer Cold & Flu Plus Congestion Day & Night Pack had a total of 8,640 boxes. Recalled by the Food and Drug Administration. (FDA) last week.
This follows the FDA’s proposal in early November to ban the use of oral phenylephrine as an over-the-counter nasal decongestant.
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After an “extensive review,” the FDA concluded that the active ingredient in the product (oral phenylephrine) is “not effective” as a nasal decongestant.
Dr. Mark Siegel, senior medical analyst for Fox News, said he agrees with the recent pushback against the ingredient.
“This chemical has been shown to be ineffective against colds and flu in oral form, except in doses containing some cardiotoxicity and palpitations, arrhythmias and High blood pressure”
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The FDA said Kirkland’s recall was related to quality control issues, noting in an official memo that “the released product should have been rejected.”
It was a Class II recall, which the FDA defines as a “situation in which use of, or exposure to, the offending product may cause temporary or clinically reversible adverse effects. Health outcomes or where the likelihood of serious health consequences is remote.”
The recalled boxes of Kirkland Severe Cold & Flu Plus Congestion had lot numbers P139953 or P139815 with an expiration date of August 2026. (ebay)
Katie Dubinsky, a New York pharmacist and founder and CEO of Vitalize, confirmed with Fox News Digital that the recall was likely due to deviations from CGMP (Current Good Manufacturing Practice).
“[That means] The product failed to meet the required quality control standards and should have been rejected prior to release.”
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“To guarantee that all products meet strict safety and quality guidelines, the FDA issues a Class II recall, which indicates a low risk to consumers and generally addresses issues that could cause serious harm. Not likely.”
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Manufacturing discrepancies and labeling errors can cause “many” CGMP deviations, according to pharmacists, as well as other procedural issues rather than ingredient issues.
“Acetaminophen, dextromethorphan, guaifenesin and phenylephrine – listed.” Active ingredients – are widely used as well as considered safe when taken as directed,” he said.
Pharmacist Katie Dubinsky told consumers to stop using the recalled lots of the product. (iStock)
Dubinsky instructed consumers to stop using the recalled lots and consult a Healthcare professional If concerns or symptoms develop after taking the product.
“However, there is no need to panic,” he said. “Recalls like these are critical to keeping products safe and helping people trust the medicines they depend on.”
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The recalled boxes of Kirkland Cold & Flow product had lot numbers P139953 or P139815 with an expiration date of August 2026.
Fox News Digital has reached out to the FDA and Costco for comment.