Reported Jan 15, 2025 · Ongoing
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99)…
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 Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only
- Distributed byRising Pharm Holdings, Inc., East Brunswick, NJ
- Lot codes and dates
a) Lot# DT3023051Aexp. date Apr-25b) DT3023025Aexp. date Jan-25
- Amount recalled
- 42,527 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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