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, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Lot numbers, UPCs & expiration codes
220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: Exp. Feb 2025
Where it was sold
US 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-0482-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 29, 2024
- FDA report date
- May 15, 2024
- Quantity
- 281,554/90 & 1000 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc
Original FDA data
Every field from FDA enforcement report D-0482-2024, exactly as published.
Show all FDA fields
- City
- Berlin
- State
- CT
- Status
- Ongoing
- Country
- United States
- Event ID
- 94483
- Address
- 15 Massirio Dr Ste 201
- Code information
- 220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: Exp. Feb 2025
- Postal code
- 06037-2352
- Report date
- May 15, 2024
- Product type
- Drugs
- Recall number
- D-0482-2024
- Classification
- Class II
- Recalling firm
- Breckenridge Pharmaceutical, Inc
- Product quantity
- 281,554/90 & 1000 count 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, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Apr 29, 2024
- Initial firm notification
- Letter
- Center classification date
- May 4, 2024