Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Product description
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
Lot numbers, UPCs & expiration codes
a) 30s; DT6023059A, DT6023060A, DT6023065A, DT6023069A, DT6023070A, exp. date Jan-25, DT6023080A, exp. date Feb-25, DT6023093A, exp. date Mar-25, DTC24012A, exp. date Dec-25; b) 90s; DT6023108A, exp. date Apr-25, DTC23201A, exp. date Aug-25; c) 1000s; DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT6022171A, DT6022169A, DT6022170A, DT6022173A, exp. date Nov-24, DT6023009A, DT6023007A, DT6023008A, DT6023011A, DT6023034B, exp. date Dec-24, DT6023067C, exp. date Jan-25, DT6023114A, exp. date Apr-25, DTC23243A, exp. date Oct-25, DTC24040A, exp. date Dec-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-0107-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 19, 2024
- FDA report date
- Dec 11, 2024
- Quantity
- 233,003 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rising Pharma Holding, Inc.
Original FDA data
Every field from FDA enforcement report D-0107-2025, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95756
- Address
- 2 Tower Center Blvd Ste 1401
- Code information
- a) 30s; DT6023059A, DT6023060A, DT6023065A, DT6023069A, DT6023070A, exp. date Jan-25, DT6023080A, exp. date Feb-25, DT6023093A, exp. date Mar-25, DTC24012A, exp. date Dec-25; b) 90s; DT6023108A, exp. date Apr-25, DTC23201A, exp. date Aug-25; c) 1000s; DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT6022171A, DT6022169A, DT6022170A, DT6022173A, exp. date Nov-24, DT6023009A, DT6023007A, DT6023008A, DT6023011A, DT6023034B, exp. date Dec-24, DT6023067C, exp. date Jan-25, DT6023114A, exp. date Apr-25, DTC23243A, exp. date Oct-25, DTC24040A, exp. date Dec-25
- Postal code
- 08816-1149
- Report date
- Dec 11, 2024
- Product type
- Drugs
- Recall number
- D-0107-2025
- Classification
- Class II
- Recalling firm
- Rising Pharma Holding, Inc.
- Product quantity
- 233,003 bottles
- Reason for recall
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
- Distribution pattern
- Nationwide.
- Recall initiation date
- Nov 19, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 5, 2024