Broncochem Cold & Tea (acetaminophen recall
FDA recall D-0387-2024 · initiated Feb 16, 2024
Global Corporation recalled Broncochem Cold & Tea (acetaminophen in Feb 2024 — an FDA Class II recall (D-0387-2024) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2345 boxes
Details
- 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
- Recalling company
- Global Corporation
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Feb 16, 2024
- FDA report date
- Mar 20, 2024
Frequently asked
- Was Broncochem Cold & Tea (acetaminophen recalled?
- Global Corporation recalled Broncochem Cold & Tea (acetaminophen in Feb 2024 — an FDA Class II recall (D-0387-2024) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Broncochem Cold & Tea (acetaminophen recalled?
- Per the FDA enforcement record, the reason for recall D-0387-2024 was: 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.
- Is a recalled Broncochem Cold & Tea (acetaminophen dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Broncochem Cold & Tea (acetaminophen are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0387-2024.