Drug & medication recalls Moderate risk

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianap…

Recall date
November 7, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0050-2025
FDA classification
Class II
Brand / firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Sold / distributed
Nationwide within the United States

Why it was recalled

Failed Impurity/Degradation Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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