Direct Rx: DULOXETINE D/R, a) 30 mg, 30 Caps; b) 30 mg, 60 Caps; CYMBALTA,
Recall reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Recalled by Direct Rx. Distribution: U.S. Nationwide. Classification (Class II — potential health risk). Affected lots/NDC/dates: Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.. Return the recalled medication to the pharmacy where you purchased it for a full refund of the purchase price.
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