Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product description
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
Lot numbers, UPCs & expiration codes
Lot #: 220128, Exp. Date 12/2024
Where it was sold
Product was distributed nationwide within the United States
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-0009-2025
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Oct 10, 2024
- FDA report date
- Oct 23, 2024
- Quantity
- 7,107 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc
Original FDA data
Every field from FDA enforcement report D-0009-2025, exactly as published.
Show all FDA fields
- City
- Berlin
- State
- CT
- Status
- Completed
- Country
- United States
- Event ID
- 95508
- Address
- 15 Massirio Dr Ste 201
- Code information
- Lot #: 220128, Exp. Date 12/2024
- Postal code
- 06037-2352
- Report date
- Oct 23, 2024
- Product type
- Drugs
- Recall number
- D-0009-2025
- Classification
- Class II
- Recalling firm
- Breckenridge Pharmaceutical, Inc
- Product quantity
- 7,107 bottles
- Reason for recall
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
- Distribution pattern
- Product was distributed nationwide within the United States
- Recall initiation date
- Oct 10, 2024
- Initial firm notification
- Letter
- Center classification date
- Oct 11, 2024