Unsafe Cold & Flu Meds Pulled by FDA Over ‘Ineffectiveness’

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Unsafe Cold & Flu Meds Pulled by FDA Over 'Ineffectiveness'
Unsafe Cold & Flu Meds Pulled by FDA Over 'Ineffectiveness'

United States: Costco brand cold and flu medicines, which are largely in the thousands, have been recalled.

The Food & Drug Administration, or FDA, revealed last week that it pulled from the market 8,640 boxes of the Kirkland Severe Cold & Flu Plus Congestion Day and Night packs.

More about the news

This was after the FDA had earlier suggested the withdrawal of sales of Oral phenylephrine as an over-the-counter nasal decongestant in early November.

After “extensive review,” it is concluded that the active ingredient in the product which is the active ingredient is “not effective” as a nasal decongestant, FDA notified.

Fox News senior medical analyst Dr. Marc Siegel told the publication that he supports the recent campaigns against the ingredient.

“This chemical is shown to be ineffective against cold and flu in its oral form, except at a dose that has some heart toxicity and can lead to palpitations, arrhythmia, and high blood pressure,” he added.

Furthermore, as the FDA said, the Kirkland recall was associated with quality control issues, and the “released product should have been rejected.”

Furthermore, the FDA described it as a Class II recall, and it is a “situation in which 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,” Fox News reported.

What more has the expert reported?

New York pharmacist and Vitalize founder and CEO Katy Dubinsky also verified with Fox News Digital that the recall likely happened because of non-compliance with CGMP (Current Good Manufacturing Practice).

“[That means] the product failed to meet required quality control standards and should have been rejected before release,” Dubinsky added.

“To guarantee all products meet strict safety and quality guidelines, the FDA made a Class II recall, which suggests low consumer risk and typically addresses issues unlikely to cause serious harm,” she continued.

The pharmacist finds that “many” of the CGMP deviations that are triggered by manufacturing inconsistencies and labeling errors are due to procedural problems rather than ingredient faults, in addition to other omissions.

Dubinsky said consumers should cease use of the recalled lots and contact a healthcare provider if they have concerns or observe symptoms after taking the product.

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