Reported Dec 11, 2024 · Ongoing
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings,…
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, 20 mg, 60 count bottles, Rx only
- Distributed byRising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
- Lot codes and dates
a) Lot # DT2022023ADT2022024ADT2022025ADT2022026ADT2022027Aexp. date Nov-24 DT2023001BDT2023004ADT2023005ADT2023006Aexp. date Jan-25
- Amount recalled
- 209,376 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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