Why it was recalled
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Product description
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
Lot numbers, UPCs & expiration codes
Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0212-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 13, 2025
- FDA report date
- Feb 5, 2025
- Quantity
- a) 6408 boxes and b)1488 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Original FDA data
Every field from FDA enforcement report D-0212-2025, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 96105
- Address
- 341 Mason Rd
- Code information
- Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025
- Postal code
- 37086-3606
- Report date
- Feb 5, 2025
- Product type
- Drugs
- Recall number
- D-0212-2025
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Product quantity
- a) 6408 boxes and b)1488 boxes
- Termination date
- Mar 5, 2026
- Reason for recall
- CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jan 13, 2025
- Initial firm notification
- Letter
- Center classification date
- Jan 29, 2025