FDAFDA · Food and drugs·Recall number D-0387-2024
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
Published March 20, 2024 · Recall initiated: February 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- BRONCOCHEM
- Manufacturer
- Global Corporation
- Distributor
- Nationwide within the United States
- UPC
- 0805418097532
- Lot
- Lot #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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