FDA recall D-0386-2024

Product

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

Reason for recall

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.

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2024-02-16

Report date

2024-03-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boca Raton, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0386-2024