Recall D-0386-2024
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
Recall D-0386-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0386-2024 |
| Event ID | 94015 |
| Distribution | Nationwide within the United States |
| Quantity | 9831 bottles |
| Recall 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. |
| Drug Classification | Class II |
| Drug Code Info | 20240320 |
| Recall Initiation Date | 20240216 |
| Report Date | 20240320 |
| Classification Date | 20240314 |
| Address | 621 Nw 53rd St Ste 240 Boca Raton, FL 33487-8291 United States |
| Recalling Firm | Global Corporation |
| Initial Notification | |
| Similar To |