FDA-Drug2025-03-26Class II
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Rising Pharma Holding, Inc.
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Sold states
Nationwide in the USA.
Affected count
1223 bottles
Manufactured in
2 Tower Center Blvd Ste 1401, N/A, East Brunswick, NJ, United States
Products
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0277-2025Don't want to check this manually?
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