D-0049-2025 Class II Terminated
FDA drug recall D-0049-2025 was initiated by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories on November 7, 2024 and is designated Class II. Reason for recall: Failed Impurity/Degradation Specifications The recall status is terminated (terminated March 5, 2026). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- November 27, 2024
- Initiation Date
- November 7, 2024
- Termination Date
- March 5, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72
Reason for Recall
Failed Impurity/Degradation Specifications
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: C00128, Exp. Date 04/2025; C00146, Exp.Date 07/2025