Recalls / Class II
Class IID-0386-2024
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
- Affected lot / code info
- Lot #: 223002, Exp. Date 10/2025; 223063, Exp. Date 02/2026
Why it was recalled
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.
Recalling firm
- Firm
- Global Corporation
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 621 Nw 53rd St Ste 240, N/A, Boca Raton, Florida 33487-8291
Distribution
- Quantity
- 9831 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-02-16
- FDA classified
- 2024-03-14
- Posted by FDA
- 2024-03-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0386-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.