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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

AvKARE Cinacalcet Tablets Recalled for Nitrosamine Impurity

Agency Publication Date: December 5, 2024
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Summary

AvKARE is recalling 55,496 bottles of Cinacalcet Tablets in 30 mg, 60 mg, and 90 mg strengths because they were found to contain an impurity called N-Nitroso-Cinacalcet that exceeds acceptable levels. This prescription medication is used to treat secondary hyperparathyroidism or high calcium levels. The affected 30-count bottles were distributed nationwide in the United States and all have an expiration date of December 31, 2024.

Risk

N-Nitroso-Cinacalcet is a type of nitrosamine impurity which is classified as a probable human carcinogen. While no immediate health issues have been reported, long-term exposure to these impurities above acceptable limits may increase the risk of developing cancer.

What You Should Do

  1. This recall affects AvKARE Cinacalcet Tablets in 30 mg, 60 mg, and 90 mg strengths, packaged in 30-count bottles with an expiration date of 12/31/2024.
  2. Check your bottle for the following NDC and lot numbers: 30 mg tablets (NDC 42291-459-30, lots 44378, 44597, 45804), 60 mg tablets (NDC 42291-460-30, lot 44550), or 90 mg tablets (NDC 42291-461-30, lot 44405).
  3. 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.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

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: Cinacalcet Tablets (30 mg)
Variants: 30 mg, 30-count bottle, Rx only
Lot Numbers:
44378 (Exp 12/31/2024)
44597 (Exp 12/31/2024)
45804 (Exp 12/31/2024)
NDC:
42291-459-30

Quantity: 50,304 bottles

Product: Cinacalcet Tablets (60 mg)
Variants: 60 mg, 30-count bottle, Rx only
Lot Numbers:
44550 (Exp 12/31/2024)
NDC:
42291-460-30

Quantity: 2,396 bottles

Product: Cinacalcet Tablets (90 mg)
Variants: 90 mg, 30-count bottle, Rx only
Lot Numbers:
44405 (Exp 12/31/2024)
NDC:
42291-461-30

Quantity: 2,796 bottles

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95897
Status: Active
Manufacturer: AvKARE
Manufactured In: United States
Units Affected: 3 products (50,304 bottles; 2,396 bottles; 2,796 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.