Drug Recall: Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc.,
Breckenridge Pharmaceutical, Inc · April 29, 2024
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product Description
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.
Distribution
US Nationwide.
States Affected
NATIONWIDE
Quantity Affected
7,188/ 500 count bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0483-2024
Status: ongoing
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