FDA Drug recall D-0387-2024
Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in t…
- FDA Drug
- Class II
- ongoing
- Published 2024-03-20
On 2024-03-20 the FDA classified a Class II recall of Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in t… 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-0387-2024 |
| 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 & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-097-12
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
| ndc | 65131-097-52 |
|---|---|
| ndc | 65131-097-53 |
| ndc | 65131-097-12 |
| code_info | Lot #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025 |
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-0387-2024%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.