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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

BluePoint Laboratories Duloxetine Capsules Recalled for Nitrosamine Impurity

Agency Publication Date: December 23, 2024
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Summary

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.

Risk

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.

What You Should Do

  1. This recall affects BluePoint Laboratories brand Duloxetine Delayed-Release Capsules USP in 30 mg and 60 mg strengths, packaged in 30, 90, and 1,000-count bottles.
  2. Check your medication bottle for NDC codes 68001-414-04, 68001-414-05, 68001-415-04, or 68001-415-08.
  3. Identify if your bottle is from one of the affected lots: DT3023029A, DT3023030A, DT6023061B, DT6022166A, or DT6023071A with expiration dates between November 2024 and February 2025.
  4. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information regarding this safety alert.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund.
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: BluePoint Laboratories Duloxetine Delayed-Release Capsules USP (30 mg, 30 count)
Variants: 30 mg, Delayed-Release Capsule
Lot Numbers:
DT3023029A (Exp 02/28/2025)
NDC:
68001-414-04

Manufactured by Aurobindo Pharma Limited.

Product: BluePoint Laboratories Duloxetine Delayed-Release Capsules USP (30 mg, 90 count)
Variants: 30 mg, Delayed-Release Capsule
Lot Numbers:
DT3023030A (Exp 2/28/2025)
NDC:
68001-414-05

Manufactured by Aurobindo Pharma Limited.

Product: BluePoint Laboratories Duloxetine Delayed-Release Capsules USP (60 mg, 30 count)
Variants: 60 mg, Delayed-Release Capsule
Lot Numbers:
DT6023061B (Exp 01/31/2025)
NDC:
68001-415-04

Manufactured by Aurobindo Pharma Limited.

Product: BluePoint Laboratories Duloxetine Delayed-Release Capsules USP (60 mg, 1,000 count)
Variants: 60 mg, Delayed-Release Capsule
Lot Numbers:
DT6022166A (Exp 11/30/2024)
DT6023071A (Exp 2/28/2025)
NDC:
68001-415-08

Manufactured by Aurobindo Pharma Limited.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95953
Status: Active
Manufacturer: Amerisource Health Services LLC
Sold By: Pharmacies nationwide
Manufactured In: India, United States
Units Affected: 4 products (21,262 bottles; 13,678 bottles; 20,734 30-count bottles; 1,815 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

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.

Find an Attorney

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.