Thousands of boxes of Kirkland Severe Cold & Flu Plus Congestion Day and Night packs have been recalled by the FDA due to the inactive ingredient's ineffectiveness and quality control issues.
A Costco-brand cold and flu medicine has been pulled from shelves by the thousands. A total of 8,640 boxes of Kirkland Severe Cold & Flu Plus Congestion Day and Night packs were recalled by the Food & Drug Administration ( FDA ) last week. This is following the FDA ’s proposal to ban the use of oral phenylephrine as an over-the-counter nasal decongestant in early November. The FDA concluded that the active ingredient in the product (oral phenylephrine) is 'not effective' as a nasal decongestant.
Dr. Marc Siegel, Fox News senior medical analyst, said he agrees with the recent pushback 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.' The FDA stated that the Kirkland recall was related to quality control issues, noting in the official recall that the 'released product should have been rejected.' This was a Class II recall, which the FDA describes as 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.' Katy Dubinsky, a New York pharmacist and founder and CEO of Vitalize, confirmed with Fox News Digital that the recall most likely occurred due to deviations from CGMP (Current Good Manufacturing Practice). ' the product failed to meet required quality control standards and should have been rejected before release,' she said
RECALLED FDA COLD AND FLU PHENYLEPHRINE QUALITY CONTROL
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