Home / Recalls / Global Corporation / D-0387-2024

D-0387-2024 Class II Ongoing

Recalled by Global Corporation — Boca Raton, FL

Recall Details

Product Type: Drugs
Report Date: March 20, 2024
Initiation Date: February 16, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2345 boxes

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

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 Pattern

Nationwide within the United States

Code Information

Lot #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025