Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product description
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
Lot numbers, UPCs & expiration codes
Lot #: 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025
Where it was sold
Nationwide in the USA
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-0562-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 17, 2024
- FDA report date
- Jun 26, 2024
- Quantity
- 165,678, 90-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc
Original FDA data
Every field from FDA enforcement report D-0562-2024, exactly as published.
Show all FDA fields
- City
- Berlin
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 94611
- Address
- 15 Massirio Dr Ste 201
- Code information
- Lot #: 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025
- Postal code
- 06037-2352
- Report date
- Jun 26, 2024
- Product type
- Drugs
- Recall number
- D-0562-2024
- Classification
- Class II
- Recalling firm
- Breckenridge Pharmaceutical, Inc
- Product quantity
- 165,678, 90-count bottles
- Termination date
- Apr 7, 2026
- 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, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 17, 2024
- Initial firm notification
- Letter
- Center classification date
- Jun 20, 2024