FDA-Drug2024-12-11Class II
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, 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
122,925 bottles
Manufactured in
2 Tower Center Blvd Ste 1401, East Brunswick, NJ, United States
Products
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0106-2025Don't want to check this manually?
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