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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 Inc.: Lovastatin (40 mg) Recalled for Failed Dissolution Specifications

Agency Publication Date: January 12, 2018
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Summary

AVKARE Inc. has recalled approximately 237 cartons of Lovastatin (lovastatin) Tablets USP, 40 mg, used for treating high cholesterol. This recall was initiated because the medication failed stability testing for dissolution, meaning the tablets may not dissolve properly in the body. If the drug does not dissolve as intended, it may not be fully absorbed, which could reduce the effectiveness of the treatment. The affected products were distributed nationwide in the USA in 50-tablet unit dose cartons.

Risk

The failure to meet dissolution standards means the medication might not be absorbed into the bloodstream at the correct rate or amount. This can result in the patient receiving a lower dose of the active ingredient than prescribed, potentially leading to poorly managed cholesterol levels.

What You Should Do

  1. Check your medication packaging for Lovastatin Tablets USP, 40 mg, in a 50-tablet (5x10) Unit Dose carton with NDC 50268-512-15.
  2. Verify if your product matches Lot number 15270 with an expiration date of 01/18.
  3. If you have the affected medication, contact your healthcare provider or pharmacist for guidance on continuing your treatment and to obtain a replacement prescription.
  4. Return any unused portions of the affected lot to your pharmacy to receive a refund.
  5. Contact AVKARE Inc. at their Pulaski, Tennessee headquarters for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall return and consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton
Model:
NDC 50268-512-15
Recall #: D-0222-2018
Lot Numbers:
15270 (Exp. 01/18)
Date Ranges: 01/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78867
Status: Resolved
Manufacturer: AVKARE Inc.
Sold By: pharmacies
Manufactured In: United States
Units Affected: 237 cartons
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.