FDA-Drug2024-03-20Class II
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
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
2345 boxes
Manufactured in
621 Nw 53rd St Ste 240, N/A, Boca Raton, FL, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0387-2024Don't want to check this manually?
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