The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2024-11-27 Health serious FDA
Health · FDA · Recall #FDA-D-0049-2025
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401… Recall
Issued November 27, 2024 · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
In November 2024, The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled the Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Impurity/Degradation Specifications
What you should do
- 1 Stop using Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Health
- Recall date
- November 27, 2024
- Units affected
- Not reported
- Sold at
- Nationwide within the United States
- Recall number
- FDA-D-0049-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 12 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.