Why it was recalled
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Product description
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Lot numbers, UPCs & expiration codes
a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, 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-0188-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 30, 2024
- FDA report date
- Jan 15, 2025
- Quantity
- 42,527 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rising Pharma Holding, Inc.
Original FDA data
Every field from FDA enforcement report D-0188-2025, 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
- a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25
- Postal code
- 08816-1149
- Report date
- Jan 15, 2025
- Product type
- Drugs
- Recall number
- D-0188-2025
- Classification
- Class II
- Recalling firm
- Rising Pharma Holding, Inc.
- Product quantity
- 42,527 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 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 30, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 8, 2025