Could cause temporary or reversible harm; serious harm is unlikely.
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.
| Distributed by / for | Global Corporation |
| NDC | 65131-098-44 |
| Full product label | 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 |
| Recalling firm | Global Corporation |
| Distribution | Nationwide within the United States |
| Quantity | 9831 bottles |
| Recall initiated | 2024-02-16 |
| Report date | 2024-03-20 |
| Recall completed | — |
| Recall number | D-0386-2024 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Boca Raton FL United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗