Class II · Moderate risk
Phenylephrine Hydrochloride Injectable Solution
cGMP deviations.
Broncochem Cold & Tea
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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
Affected NDC
65131-0097-12
Compare with the code on your package — it is the most precise check available.
Drug: Phenylephrine Category: Pain Relief & OTC Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Broncochem Cold and Flu Tea Acetaminophen-Phenylephrine Hydrochloride-Chlorpheniramine Maleate NDC 65131-0097 |
ACETAMINOPHEN 500 mg/13g; CHLORPHENIRAMINE MALEATE 4 mg/13g | Granule, for Solution Oral |
Laboratorio Magnachem International Srl | OTC |
- Recalling firm
- Global Corporation
- NDC code
- 65131-097-12
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0387-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Phenylephrine recalls
See all
Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Incorrect Product Formulation
Class II · Moderate risk
Phenylephrine HCI
CGMP Deviations
Class III · Low risk
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Leaking/damaged syringes.
Other recalls by Global Corporation
All 2024 recalls
Class II · Moderate risk
Broncochem Cold & Flu Syrup Kids
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.
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