Reported Jan 1, 2025 · Ongoing
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC…
RemedyRepack Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RemedyRepack Inc. · 625 Kolter Dr Ste 4 · Indiana, PA · 15701-3571
Is this the product you have?
- 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
- MFGRising Pharma, Inc., Allendale, NJ
- Repackaged byRemedyRepack Inc., Indiana, PA
- Lot codes and dates
a) NDC 70518-0937-04Lot # J0786744-061724Exp. 06/30/2025 b) NDC 70518-0937-03Lot # B3002625-060524Exp. 10/31/2025
- Amount recalled
- a) 1,564 cards, b) 799 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
This product could cause temporary or reversible health problems — stop using it.
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