Why it was recalled
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Product description
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Lot numbers, UPCs & expiration codes
Lot # 222205C, exp. date 11/2025
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-0161-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 6, 2024
- FDA report date
- Jan 1, 2025
- Quantity
- 163,883 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc
Original FDA data
Every field from FDA enforcement report D-0161-2025, exactly as published.
Show all FDA fields
- City
- Berlin
- State
- CT
- Status
- Ongoing
- Country
- United States
- Event ID
- 95853
- Address
- 15 Massirio Dr Ste 201
- Code information
- Lot # 222205C, exp. date 11/2025
- Postal code
- 06037-2352
- Report date
- Jan 1, 2025
- Product type
- Drugs
- Recall number
- D-0161-2025
- Classification
- Class II
- Recalling firm
- Breckenridge Pharmaceutical, Inc
- Product quantity
- 163,883 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, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Dec 6, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 23, 2024