FDA Drug Class II — Moderate

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

Hazard

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

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Products

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
Brand
Breckenridge Pharmaceutical, Inc.
UPC
Lot 240927C, Exp 04/30/2027

Units Affected

3,591 bottles

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