DULoxetine tablets recalled for excess nitrosamine impurity
PD-Rx Pharmaceuticals recalls DULoxetine DR 30 mg tablets due to excess nitrosamine impurity above acceptable limits. The affected lots were distributed in Florida, Mississippi, and Wisconsin.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II drug recall for a manufacturing deviation resulting in a nitrosamine impurity above acceptable intake limits. This is classified as a risk-of-harm product due to potential carcinogenic effects from long-term exposure above acceptable levels, though no illnesses have been reported.
Plain-English summary
PD-Rx Pharmaceuticals, Inc. is recalling DULoxetine DR 30 mg tablets in 90-count bottles due to the presence of N-Nitroso-Duloxetine, a nitrosamine impurity, above the FDA's interim acceptable intake limit. The recall involves 70 bottles with lot numbers I24E77, A24E49 (expiration 04/30/2025) and J23C50, J23C97, L23B39, L23E98 (expiration 01/31/2025).
The contamination was identified as a manufacturing deviation from Current Good Manufacturing Practice standards. No adverse health effects have been reported to date; however, the impurity presents a potential health risk from long-term exposure above acceptable levels.
The affected product was distributed in Florida, Mississippi, and Wisconsin. Patients currently taking this medication should contact their healthcare provider or pharmacist. Do not discontinue DULoxetine without consulting your healthcare provider first.
The recalled product
- Product
- DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Category
- Drug — Antidepressant
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot # I24E77
- A24E49
- Exp Date: 04/30/25
- J23C50
- J23C97
- L23B39
- L23E98
- Exp Date: 01/31/2025
Distribution
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