The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-02-05 Health serious FDA
Health · FDA · Recall #FDA-D-0212-2025
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10… Recall
Issued February 5, 2025 · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
In February 2025, The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled the Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
What you should do
- 1 Stop using Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10… 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
- February 5, 2025
- Units affected
- Not reported
- Sold at
- Nationwide within the United States
- Recall number
- FDA-D-0212-2025
- 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 691st Health recall we've logged in 2025.