Drug Recall: 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., Allenda
RemedyRepack Inc. · December 2, 2024
Reason for Recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Product Description
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
Distribution
Nationwide in the US
States Affected
NATIONWIDE
Quantity Affected
a) 1,564 cards, b) 799 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0165-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.