Guaifenesin Dextromethorphan Syrup Recalled for Failed Quality Specifications
Major Pharmaceuticals has recalled Guaifenesin Dextromethorphan Syrup due to failed impurity and degradation specifications. Three lot numbers were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for failed quality specifications. The product qualifies as a risk-of-harm product with no reported illnesses or injuries, meeting the rubric criterion for a High severity score.
Plain-English summary
The Harvard Drug Group LLC, operating as Major Pharmaceuticals and Rugby Laboratories, is recalling Guaifenesin Dextromethorphan Syrup (100 mg/10mg per 5 mL) due to failed impurity and degradation specifications. The affected product was manufactured and distributed nationwide.
The recalled product is identified by NDC 0904-7134-70, manufactured at 8401 Bearing Drive, Suite 100, Indianapolis, IN 46268. Three lots are affected: Lot C00113 with expiration date 11/2024, Lot C00125 with expiration date 04/2025, and Lot C00145 with expiration date 07/2025.
Consumers who have this product should consult the recall notice or contact their pharmacy or healthcare provider for guidance. Do not use the recalled product if you have one of the affected lot numbers.
The recalled product
- Product
- Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Drug — Cough and Cold Syrup
- Hazard
- impurity
- degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: C00113
- Exp. Date 11/2024
- C00125
- Exp. Date 04/2025
- C00145
- Exp. Date 07/2025
Distribution
Distributed nationwide across the United States.
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