Drug Recall: Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berk
Breckenridge Pharmaceutical, Inc · May 17, 2024
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product Description
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
165,678, 90-count bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0562-2024
Status: terminated
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