FDA-Drug2024-03-20Class II
Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44
Global Corporation
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.
Sold states
Nationwide within the United States
Affected count
9831 bottles
Manufactured in
621 Nw 53rd St Ste 240, N/A, Boca Raton, FL, United States
Products
Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0386-2024Don't want to check this manually?
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