Class II
Ongoing
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
This recall is currently active, issued March 20, 2024. It was issued by Global Corporation.
- Company
- Global Corporation
- Recall Initiated
- February 16, 2024
- Posted
- March 20, 2024
- Recall Number
- D-0386-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9831 bottles
- Firm Location
- Boca Raton, FL, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot #: 223002, Exp. Date 10/2025; 223063, Exp. Date 02/2026
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