Class II
Ongoing
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
- Recall Initiated
- July 25, 2025
- Posted
- August 20, 2025
- Recall Number
- D-0580-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,856 bottles
- Firm Location
- Berkeley Heights, NJ, United States
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Distribution
NJ, AZ, IN
Lot / Code Info
Lot 240539C, Exp 1/31/2027
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