OTC Cold Meds Recalled

Ultra Seal Corporation is recalling a slate of cold and sinus relief medications manufactured for various clients and distributed throughout the United States. According to the February 9, 2022, US Food and Drug Administration (FDA) Enforcement Report, the products are being recalled due to deviations from Current Good Manufacturing Practice regulations.

The recall includes the following over-the-counter cold and sinus medications:

• Cetafen Cough & Cold Relief (acetaminophen 325 mg, dextromethorphan HBr 15 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg), 2-tablet packets from lot AK9841 (Exp. 10/22), manufactured for HART Health, Seattle, WA;
• Chloresin (acetaminophen 325 mg, dextromethorphan HBr 15 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg), 2-tablet packets (NDC 51532-0107-2) from lot AK9492 (Exp. 2/22), manufactured for Afassco Inc, Minden, NV;
• Cold Relief (acetaminophen 250 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg), 2-tablet packets (NDC 42961-112-03) from lots K9456 (Exp. 1/22), AK9454 (Exp. 1/22), 9456 (Exp. 1/22), AK9456 (Exp. 1/22), AK9524 (Exp. 3/22), AK9528 (Exp. 3/22), K9767 (Exp. 8/22), AK9767 (Exp. 8/22), AK9824 (Exp. 9/22), AK9823 (Exp. 9/22), and AK9564 (Exp. 4/22), manufactured for First Aid Direct, Mason, OH;
• Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg), 2-tablet packets from lot K9824 (Exp. 9/22), manufactured for Respond Industries and American First Aid, Mason, OH;
• Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, phenylephrine HCl 5 mg), 2-tablet packets from lot K9708 (Exp. 7/22), manufactured for Respond Industries and American First Aid, Mason, OH;
• Cold Terminator (acetaminophen 325 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg), 2-tablet packets (NDC 69103-2556) from lot AK9587 (Exp. 2/22), manufactured for Tellus Medical Products, Carlsbad, CA;
• Multi Symptom Cold Relief (acetaminophen 325 mg, dextromethorphan HBr 15 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg), 2-tablet packets from lots AK9715 and K9715 (Exp. 7/22), distributed by Honeywell Safety Products USA, Smithfield, RI; and
• Cold Relief Severe Pain/Cough (acetaminophen 325 mg, dextromethorphan HBr 15 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg), 2-tablet packets from lot AK9436 (Exp. 1/22), manufactured for Select Corporation, Carrollton, TX.

Ultra Seal Corporation voluntarily initiated the recalls January 24, 2022. On January 31, 2022, the FDA designated them Class II. The recall classification signals that use of the products could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.