FDA-Drug2025-01-15Class II
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm 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
42,527 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) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0188-2025Don't want to check this manually?
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