Drug product

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

D-0050-2025

November 07, 2024

Class II

Product summary

Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Event: Event 95705
Status: Terminated
Classification: Class II
Quantity: N/A
Official record key: drug-enforcement:D-0050-2025

Reason: Failed Impurity/Degradation Specifications

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

Distribution pattern: Nationwide within the United States

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Failed Impurity/Degradation Specifications