FDA-Drug2024-12-11Class II
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
Rising Pharma Holding, Inc.
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Sold states
Nationwide.
Affected count
233,003 bottles
Manufactured in
2 Tower Center Blvd Ste 1401, East Brunswick, NJ, United States
Products
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0107-2025Don't want to check this manually?
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