RemedyRepack Inc. recalls Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 7051
Recalled January 1, 2025 · FDA recall D-0165-2025 · RemedyRepack
Hazard
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit. · FDA Class II
Units
a) 1,564 cards, b) 799 bottles
Sold at
Nationwide in the US
Description
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Product
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
Manufacturer(s)
RemedyRepack Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →