Global Corporation: Drug Recall

Recall #D-0387-2024 · 02/16/2024

Class II: Risk

Recall Details

Recall Number: D-0387-2024
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: 2345 boxes

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 & 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

Distribution Pattern

Nationwide within the United States

Other Recalls by Global Corporation

Class II: Risk 02/16/2024

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.

View all recalls by Global Corporation →

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.