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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Elite Laboratories Inc.: Isradapine Capsules Recalled for Failed Impurities and Degradation Specs

Agency Publication Date: December 5, 2017
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Summary

Elite Laboratories Inc. is recalling 1,264 bottles of Isradapine Capsules USP 2.5 mg because the medication failed to meet quality specifications for impurities and degradation. This recall affects 100-count bottles of the prescription blood pressure medication that were distributed only in New York. While no injuries or adverse effects have been reported, consumers should check their prescription bottles immediately to see if they have the affected lot.

Risk

The medication has failed stability testing for impurities, meaning the chemical composition of the drug may have changed over time. This can reduce the effectiveness of the treatment or potentially expose the patient to unintended degradation byproducts.

What You Should Do

  1. Check your prescription bottle for Isradapine Capsules USP 2.5 mg (100-count) with NDC 42806-263-01 and UPC 342806263013.
  2. Verify if your bottle belongs to Lot # P0910-017 with an expiration date of 05/2019.
  3. If you have the affected medication, contact your healthcare provider or pharmacist immediately for guidance on a replacement and to ensure your treatment is not interrupted.
  4. Return any unused product from this specific lot to your pharmacy for a refund.
  5. Contact Elite Laboratories Inc. at their Northvale, NJ facility if you have further questions regarding the return of the product.
  6. For additional information 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

Contact healthcare provider and return product to pharmacy.

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

Affected Products

Product: Isradapine Capsules USP 2.5 mg (100-count bottle)
Model:
NDC 42806-263-01
UPC Codes:
342806263013
Lot Numbers:
P0910-017 (Exp. 05/2019)
Date Ranges: Expiration Date: 05/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78502
Status: Resolved
Manufacturer: Elite Laboratories Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 1264 bottles
Distributed To: New York

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.