Broncochem Cold & Tea — Class II drug recall D-0387-2024
Ongoing recall by Global Corporation, reported 2024-03-20, distributed nationwide. Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished dru
| Recall number | D-0387-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Global Corporation, Boca Raton, FL, United States |
| Recall initiated | 2024-02-16 |
| Classified | 2024-03-14 |
| Reported by FDA | 2024-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 2,345 boxes |
| Reason classes | specification failure |
| NDC | 65131-0097, 65131-0097-12, 65131-0097-52, 65131-0097-53 |
| Lot numbers | 123255, 123256, 123637 |
| Expiration dates | 2024-11, 2025-03 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0387-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.