Fox Health: Costco-brand cold and flu medication recalled by FDA: 'Not effective'

[riky]

Costco-brand cold and flu medication recalled by FDA: 'Not effective'

Thousands of boxes of Kirkland Severe Cold & Flu have been recalled for quality control issues. Pharmacist Katy Dubinsky addresses potential health ramifications.
                       
                       
                           

A Costco-brand You are not allowed to view links. Register or Login 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 You are not allowed to view links. Register or Login (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.

You are not allowed to view links. Register or Login

After "extensive review," 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 You are not allowed to view links. Register or Login."

You are not allowed to view links. Register or Login

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 You are not allowed to view links. Register or Login 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).

"[That means] the product failed to meet required quality control standards and should have been rejected before release," she said.

You are not allowed to view links. Register or Login

"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."

You are not allowed to view links. Register or LoginYou are not allowed to view links. Register or Login

Manufacturing inconsistencies and labeling errors can cause "many" CGMP deviations, according to the pharmacist, as well as other procedural issues rather than ingredient problems.

"Acetaminophen, dextromethorphan, guaifenesin and phenylephrine – the listed You are not allowed to view links. Register or Login – are widely used as well as considered safe when taken as directed," she said.

Dubinsky instructed consumers to stop using the recalled lots and consult with a You are not allowed to view links. Register or Login if concerns or symptoms arise after taking the product.

"However, there is no need for panic," she said. "Recalls like this are important to keep products safe and help people trust the over-the-counter medications they rely on."

Recalled boxes of the Kirkland Cold & Flu product had lot numbers P139953 or P139815 with an August 2026 expiration date.

Fox News Digital reached out to the FDA and Costco for comment.

Source: You are not allowed to view links. Register or Login