Cold and Flu Relief Medication Recalled

New Vision Pharmaceuticals is recalling two lots of CVS Health Daytime Severe Cold & Flu Relief (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride) because the medication is subpotent, according to the October 6, 2021, US Food and Drug Administration (FDA) Enforcement Report.  

The recall affects CVS Health Daytime Severe Cold & Flu Relief, mixed berry flavor, packaged in boxes of 8 premeasured vials containing 15 ml each (NDC 69842-499-08, UPC 0 50428 64130 9), from lots 2021-10154 (Exp. 6/29/23) and 2021-10164 (Exp. 6/11/23). The boxes were distributed in 14 states: Alabama, California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, and Virginia. 

New Vision Pharmaceuticals voluntarily initiated the recall September 2, 2021. On September 24, 2021, the FDA designated the recall Class III. Under the recall classification, use of the affected medication is not likely to cause harm.

CVS Health Daytime Severe Cold & Flu Relief is an over-the-counter pain reliever, fever reducer, cough suppressant/expectorant, and nasal decongestant.