D-0386-2024 Class II Ongoing
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