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FDADecember 30, 2024drug

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

What to do

FDA enforcement status: Ongoing

Brands named

rising pharma holdingrisingrising pharma

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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