The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories: Drug Recall

Recall #D-0049-2025 · 11/07/2024

Class II: Risk

Recall Details

Recall Number
D-0049-2025
Classification
Class II
Product Type
Drug
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Status
Completed
Date Initiated
11/07/2024
Location
La Vergne, TN, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Reason for Recall

Failed Impurity/Degradation Specifications

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

Distribution Pattern

Nationwide within the United States

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.