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 & 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
Lot numbers, UPCs & expiration codes
Lot #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025
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-0387-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 16, 2024
- FDA report date
- Mar 20, 2024
- Quantity
- 2345 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Global Corporation
Original FDA data
Every field from FDA enforcement report D-0387-2024, 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 #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025
- Postal code
- 33487-8291
- Report date
- Mar 20, 2024
- Product type
- Drugs
- Recall number
- D-0387-2024
- Classification
- Class II
- Recalling firm
- Global Corporation
- Product quantity
- 2345 boxes
- 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 & 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 16, 2024
- Initial firm notification
- Center classification date
- Mar 14, 2024