Drug recall D-0621-2025
Product
Duloxetine Delayed-Release Capsules, USP, 30 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: 82009-030-10
Reason for recall
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Lots and codes
Lot 240927C, Exp 04/30/2027
Recall details
- Recalling firm
- Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
- Quantity
- 3,591 bottles
- Distribution
- AZ, IN, NJ
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 8, 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