Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in ...
FDA Recall #D-0387-2024 — Class II — February 16, 2024
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.
Recalling Firm
Global Corporation — Boca Raton, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2345 boxes
Distribution
Nationwide within the United States
Code Information
Lot #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated