Drug Recall: 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 Pha
Breckenridge Pharmaceutical, Inc. · August 8, 2025
Reason for Recall
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Product Description
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
Distribution
AZ, IN, NJ
States Affected
AZ, IN, NJ
Quantity Affected
3,591 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0621-2025
Status: ongoing
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