# FDA recall D-0387-2024

> **Global Corporation** · Class II · drug recall initiated 2024-02-16.

## 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.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0387-2024
- **Recalling firm:** Global Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-02-16
- **Report date:** 2024-03-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boca Raton, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0387-2024

## Citation

> AI Analytics. FDA recall D-0387-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0387-2024. Source: US FDA. Licensed CC0.

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