Recalls / Class II
Class IID-0387-2024
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
- Brand name
- Broncochem
- Generic name
- Acetaminophen-phenylephrine Hydrochloride-chlorpheniramine Maleate
- Active ingredients
- Acetaminophen, Chlorpheniramine Maleate
- Route
- Oral
- NDC
- 65131-097
- FDA application
- M
- Affected lot / code info
- Lot #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025
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.
Recalling firm
- Firm
- Global Corporation
- Manufacturer
- LABORATORIO MAGNACHEM INTERNATIONAL SRL
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 621 Nw 53rd St Ste 240, N/A, Boca Raton, Florida 33487-8291
Distribution
- Quantity
- 2345 boxes
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-02-16
- FDA classified
- 2024-03-14
- Posted by FDA
- 2024-03-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0387-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.