FDA Drug Class II — Moderate

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.

Hazard

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

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Products

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmac
Brand
Breckenridge Pharmaceutical, Inc.
UPC
Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.

Units Affected

7389 bottles

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