Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120...
FDA Recall #D-0386-2024 — Class II — February 16, 2024
Product Description
Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44
Reason for Recall
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Recalling Firm
Global Corporation — Boca Raton, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
9831 bottles
Distribution
Nationwide within the United States
Code Information
Lot #: 223002, Exp. Date 10/2025; 223063, Exp. Date 02/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated