Why it was recalled
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Product description
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Lot numbers, UPCs & expiration codes
Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25
Where it was sold
Nationwide
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-0189-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 30, 2024
- FDA report date
- Jan 15, 2025
- Quantity
- 73,680 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rising Pharma Holding, Inc.
Original FDA data
Every field from FDA enforcement report D-0189-2025, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96074
- Address
- 2 Tower Center Blvd Ste 1401
- Code information
- Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25
- Postal code
- 08816-1149
- Report date
- Jan 15, 2025
- Product type
- Drugs
- Recall number
- D-0189-2025
- Classification
- Class II
- Recalling firm
- Rising Pharma Holding, Inc.
- Product quantity
- 73,680 bottles
- Reason for recall
- CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 30, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 8, 2025