Why it was recalled
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Product description
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Lot numbers, UPCs & expiration codes
a) NDC 70518-0937-04, Lot # J0786744-061724, Exp. 06/30/2025 b) NDC 70518-0937-03, Lot # B3002625-060524, Exp. 10/31/2025
Where it was sold
Nationwide in the US
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-0165-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 2, 2024
- FDA report date
- Jan 1, 2025
- Quantity
- a) 1,564 cards, b) 799 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0165-2025, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 95900
- Address
- 625 Kolter Dr Ste 4
- Code information
- a) NDC 70518-0937-04, Lot # J0786744-061724, Exp. 06/30/2025 b) NDC 70518-0937-03, Lot # B3002625-060524, Exp. 10/31/2025
- Postal code
- 15701-3571
- Report date
- Jan 1, 2025
- Product type
- Drugs
- Recall number
- D-0165-2025
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- a) 1,564 cards, b) 799 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, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Dec 2, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 26, 2024