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), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
Lot numbers, UPCs & expiration codes
a) 30s; DT3023019A, exp. date Jan-25 DT3023050A, exp. date Apr-25; b) 90s; DT3023022A, exp. date Jan-25; c) 1000s; DT3022108A, DT3022107A, DT3022106A, DT3022111A, DT3022109A, exp. date Nov-24, DT3023001A, DT3023003A, exp. date Dec-24, DT3023024A, DT3023020B, exp. date Jan-25 DT3023027A, DT3023028A, exp. date Feb-25, DT3023034A, exp. date Mar-25, DT3023049A, exp. date Apr-25, DT3023095A, exp. date Jul-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-0106-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 19, 2024
- FDA report date
- Dec 11, 2024
- Quantity
- 122,925 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rising Pharma Holding, Inc.
Original FDA data
Every field from FDA enforcement report D-0106-2025, 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; DT3023019A, exp. date Jan-25 DT3023050A, exp. date Apr-25; b) 90s; DT3023022A, exp. date Jan-25; c) 1000s; DT3022108A, DT3022107A, DT3022106A, DT3022111A, DT3022109A, exp. date Nov-24, DT3023001A, DT3023003A, exp. date Dec-24, DT3023024A, DT3023020B, exp. date Jan-25 DT3023027A, DT3023028A, exp. date Feb-25, DT3023034A, exp. date Mar-25, DT3023049A, exp. date Apr-25, DT3023095A, exp. date Jul-25
- Postal code
- 08816-1149
- Report date
- Dec 11, 2024
- Product type
- Drugs
- Recall number
- D-0106-2025
- Classification
- Class II
- Recalling firm
- Rising Pharma Holding, Inc.
- Product quantity
- 122,925 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), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
- Distribution pattern
- Nationwide.
- Recall initiation date
- Nov 19, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 5, 2024