NEW YORK POST – An off-brand version of Dayquil and Nyquil has been recalled due to substandard quality.
Last week, the U.S. Food and Drug Administration (FDA) recalled 8,640 boxes of Kirkland Signature Severe Cold & Flu Plus Congestion, a product sold at Costco.
One of the key ingredients in the Kirkland product is oral phenylephrine, which is facing an FDA ban due to ineffectiveness.
Last year, an outside panel of experts unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant, adding that no more trials were required to prove otherwise.
However, the recall is unrelated to phenylephrine, but rather quality control issues.
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The medicine is a 168-count twin pack that pairs 112 coated caplets for day and 56 for night use.
The box is designed to emphasize the dual function, while the color scheme invokes Nyquil and Dayquil packaging, with orange representing day use and blue, evening. The words Severe Cold and Flu appear in white block lettering at the top of the box.
The package retails for $15.99.
According to the FDA, the medication was recalled due to “CGMP deviations,” meaning the product was not made to the standard of the quality control regulations known as Current Good Manufacturing Practices.
The report notes that the product “should have been rejected” but does not disclose what specific quality measures it defaulted on.
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According to the National Institutes of Health’s (NIH) National Library of Medicine, the daytime meds featured in the Kirkland product are formulated to reduce pain and fever, suppress cough, lubricate the airways and promote decongestion. The evening capsules include added antihistamines to treat throat and nasal symptoms and induce drowsiness.
The label features several identifying pieces of information to help you discern if you have purchased the compromised cold meds:
- National Drug Code/NDC number: 63981-795-81
- Lot numbers: P139953 or P139815
- Expiration date: August 2026