Duloxetine Delayed-Release Capsules Recalled Nationwide for Excess N-Nitroso Impurity
Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity above recommended limits. The affected product was distributed nationwide in 1,815 bottles with two specific lot numbers and expiration dates.
What this means for you
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 recall with a chemical impurity representing a manufacturing deviation. N-nitroso compounds are known genotoxic/carcinogenic impurities, qualifying this as a risk-of-harm product where injury has not been reported, meeting the rubric criteria for High severity.
Plain-English summary
Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules, USP, 60 mg (prescription only) due to the presence of N-nitroso-duloxetine impurity above the recommended interim limit. This represents a Current Good Manufacturing Practice (CGMP) deviation.
The affected product includes 1,815 bottles of Duloxetine delayed-release capsules manufactured by Aurobindo Pharma Limited for BluePoint Laboratories (NDC 68001-415-08). The recalled lots are Lot DT6022166A (expiration 11/30/2024) and Lot DT6023071A (expiration 2/28/2025). The product was distributed nationwide throughout the United States.
N-nitroso-duloxetine is a chemical impurity. The FDA has established interim limits for acceptable levels of this impurity in medications. Patients currently taking the recalled product should consult their healthcare provider before making any changes to their treatment.
The recalled product
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Antidepressant
- Hazard
- n-nitroso-impurity
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 (5)
- Lots
- expiry: Lot DT6022166A
- exp 11/30/2024
- Lot DT6023071A
- exp 2/28/2025
Distribution
Distributed nationwide across the United States.
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