FDA Drug recall D-0386-2024
Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Ex…
- FDA Drug
- Class II
- ongoing
- Published 2024-03-20
On 2024-03-20 the FDA classified a Class II recall of Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Ex… by Global, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0386-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-16 |
| Published | 2024-03-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Global |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot #: 223002, Exp. Date 10/2025; 223063, Exp. Date 02/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0386-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.