Amerisource Health Services LLC is recalling 57,489 bottles of BluePoint Laboratories Duloxetine Delayed-Release Capsules (30 mg and 60 mg). The recall was issued because the medication was found to contain an impurity called N-nitroso-duloxetine at levels that exceed the FDA's recommended safety limits. Duloxetine is a prescription medication commonly used to treat depression, anxiety, and certain chronic pain conditions. Patients should not stop taking their medication without first talking to their healthcare provider or pharmacist, as the risks of stopping suddenly may outweigh the risks associated with the impurity.
The capsules contain a nitrosamine impurity, which is a substance classified as a probable human carcinogen. Long-term exposure to these impurities above specific levels may increase the risk of developing cancer.
You have 2 options:
Manufactured by Aurobindo Pharma Limited.
Manufactured by Aurobindo Pharma Limited.
Manufactured by Aurobindo Pharma Limited.
Manufactured by Aurobindo Pharma Limited.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES ยท Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.