D-0386-2024 Class II Ongoing

Recalled by Global Corporation — Boca Raton, FL

Recall Details

Product Type
Drugs
Report Date
March 20, 2024
Initiation Date
February 16, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9831 bottles

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.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 223002, Exp. Date 10/2025; 223063, Exp. Date 02/2026