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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 223002, Exp. Date 10/2025; 223063, Exp. Date 02/2026
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0386-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 16, 2024
- FDA report date
- Mar 20, 2024
- Quantity
- 9831 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Global Corporation
Original FDA data
Every field from FDA enforcement report D-0386-2024, exactly as published.
Show all FDA fields
- City
- Boca Raton
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 94015
- Address
- 621 Nw 53rd St Ste 240
- Code information
- Lot #: 223002, Exp. Date 10/2025; 223063, Exp. Date 02/2026
- Postal code
- 33487-8291
- Report date
- Mar 20, 2024
- Product type
- Drugs
- Recall number
- D-0386-2024
- Classification
- Class II
- Recalling firm
- Global Corporation
- Product quantity
- 9831 bottles
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 16, 2024
- Initial firm notification
- Center classification date
- Mar 14, 2024