OTC Cold and Flu Products Recalled

Failures in stability testing for active pharmaceutical ingredients prompted the recall of 9831 bottles of Broncochem Kids Cold & Flu Syrup and 2345 boxes of Broncochem Cold & Flu Tea. The recalls appeared in the March 20, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recalls affect the following products, which were made in the Dominican Republic exclusively for Global Corporation Inc., Boca Raton, Florida, and distributed throughout the United States:

• Broncochem Kids Cold & Flu Syrup (acetaminophen, guaifenesin, phenylephrine hydrochloride), packaged in 120-mL bottles (NDC 65131-098-44), from lots 223002 (Exp. 10/25) and 223063 (Exp. 2/26); and
• Broncochem Cold & Flu Tea (acetaminophen, phenylephrine hydrochloride, chlorpheniramine maleate), packaged in 13-g sachets, 25 sachets per box (NDC 65131-097-12), from lots 123255 (Exp. 11/24), 123256 (Exp. 11/24), and 123637 (Exp. 3/25).

Global Corporation voluntarily initiated the recalls on February 16, 2024. On March 14, 2024, the FDA designated them Class II. The classification communicates that use of the products may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Broncochem products are sold over the counter for the management of cold and flu symptoms.