Drug recall D-0269-2025
Product
Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Lots and codes
Lot#: 240301C, Expiration: 01/2027.
Recall details
- Recalling firm
- Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
- Quantity
- 11,100 bottles.
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 28, 2025
Related products
- Duloxetine – drug information
- NDC 51991-747 Duloxetine Delayed-Release · Duloxetine Hydrochloride 30 mg/1 · Breckenridge Pharmaceutical, Inc.
- NDC 51991-750 Duloxetine Delayed-Release · Duloxetine Hydrochloride 40 mg/1 · Breckenridge Pharmaceutical, Inc.
- NDC 51991-748 Duloxetine Delayed-Release · Duloxetine Hydrochloride 60 mg/1 · Breckenridge Pharmaceutical, Inc.
- NDC 51991-746 Duloxetine Delayed-Release · Duloxetine Hydrochloride 20 mg/1 · Breckenridge Pharmaceutical, Inc.