Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-Release Capsules, USP,
Recall reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Recalled by Breckenridge Pharmaceutical, Inc.. Distribution: Nationwide within the United States. Classification (Class II — potential health risk). Affected lots/NDC/dates: Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 202. Return the recalled medication to the pharmacy where you purchased it for a full refund of the purchase price.
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