Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-Release Capsules, USP, 60
Recall reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.. Recalled by Breckenridge Pharmaceutical, Inc.. Distribution: NJ, AZ, IN. Classification (Class II — potential health risk). Affected lots/NDC/dates: Lot 240539C, Exp 1/31/2027. Return the recalled medication to the pharmacy where you purchased it for a full refund of the purchase price.
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