FDAFebruary 16, 2024drug
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
global
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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