Class IIOngoing

Broncochem Cold & Tea (acetaminophen recall

FDA recall D-0387-2024 · initiated Feb 16, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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.

Details

Product: 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
Recalling company: Global Corporation
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the United States
Initiated: Feb 16, 2024
FDA report date: Mar 20, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0387-2024 ↗

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