Global Corporation: Drug Recall
Recall #D-0386-2024 · 02/16/2024
Class II: Risk
Recall Details
- Recall Number
- D-0386-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Global Corporation
- Status
- Ongoing
- Date Initiated
- 02/16/2024
- Location
- Boca Raton, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9831 bottles
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.
Product Description
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
Distribution Pattern
Nationwide within the United States
Other Recalls by Global Corporation
- Class II: Risk 02/16/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.