FDA Drugs recall ·
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL… recall
- Recall number
- D-0050-2025
- Date
- (initiated November 7, 2024)
- Company / brand
- Major Pharmaceuticals and Rugby Laboratories
341 Mason Rd, La Vergne, TN, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- N/A
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
Why was it recalled?
Failed Impurity/Degradation Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: C00113, Exp. Date 11/2024; C00125, Exp. Date 04/2025; C00145, Exp. Date 07/2025
Distribution
Nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0050-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.