Reported Jan 15, 2025 · Ongoing
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles;…
Rising Pharma Holding, 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: Rising Pharma Holding, Inc. · 2 Tower Center Blvd Ste 1401 · East Brunswick, NJ · 08816-1149
Is this the product you have?
- Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles
- Distributed byRising Pharm Holdings, Inc., East Brunswick, NJ
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Lot # a) DT6023053A, DT6023061A, DT6023068A, DT6023074A, exp. date Jan-25 2 DT6023078A, DT6023076A, exp. date Feb-25 3 DTC24043A, DTC24044A, exp. date Dec-25 b) DT6023002A, DT6023016A, DT6023036A, exp. date Dec-24 4 DT6023048A, exp. date Jan-25 - Amount recalled
- 244,460 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
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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