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Drug FDA Class II Terminated Failed specifications

Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Published Nov 27, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Impurity/Degradation Specifications

Hazards

Failed Impurity/Degradation Specifications · primary

Affected products (1)

Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70

N/A

Code info: Lot #: C00113, Exp. Date 11/2024; C00125, Exp. Date 04/2025; C00145, Exp. Date 07/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 7, 2024
  2. Published
    Nov 27, 2024
  3. Terminated
    Mar 5, 2026
Recall number
D-0050-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.