Drug recall D-0580-2025
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Lots and codes
Lot 240539C, Exp 1/31/2027
Recall details
- Recalling firm
- Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
- Quantity
- 1,856 bottles
- Distribution
- NJ, AZ, IN
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 25, 2025
Related products
- Duloxetine – drug information
- NDC 82009-032 Duloxetine · Duloxetine Hydrochloride 60 mg/1 · Quallent Pharmaceuticals Health, LLC
- NDC 82009-030 Duloxetine · Duloxetine Hydrochloride 30 mg/1 · Quallent Pharmaceuticals Health, LLC
- NDC 82009-031 Duloxetine · Duloxetine Hydrochloride 40 mg/1 · Quallent Pharmaceuticals Health, LLC
- NDC 82009-029 Duloxetine · Duloxetine Hydrochloride 20 mg/1 · Quallent Pharmaceuticals Health, LLC