Reported Jan 1, 2025 · Terminated
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127,…
PD-Rx Pharmaceuticals, 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: PD-Rx Pharmaceuticals, Inc. · 727 N Ann Arbor Ave · Oklahoma City, OK · 73127-5822
Is this the product you have?
- DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only
- Packaged byPD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127
- NDC43063-877-90
- Lot codes and dates
Lot # I24E77A24E49
- Exp Date
04/30/25J23C50J23C97L23B39L23E98
- Exp Date01/31/2025
- Amount recalled
- 70, 90-count bottles
Where it was sold
Why it was recalled
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
This product could cause temporary or reversible health problems — stop using it.
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