Drug product
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
D-0386-2024
Product summary
- Event
- Event 94015
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9831 bottles
- Official record key
drug-enforcement:D-0386-2024
Official wording
Reason: 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.
Code information: Lot #: 223002, Exp. Date 10/2025; 223063, Exp. Date 02/2026
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
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.