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

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.