FDA-Drug2025-01-01Class II
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
RemedyRepack Inc.
Hazard
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Sold states
Nationwide in the US
Affected count
a) 1,564 cards, b) 799 bottles
Manufactured in
625 Kolter Dr Ste 4, Indiana, PA, United States
Products
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0165-2025Don't want to check this manually?
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