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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

Jubilant Cadista Pharmaceuticals, Inc.: Itraconazole Capsules Recalled Due to Failed Dissolution Specifications

Agency Publication Date: April 12, 2021
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Summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling approximately 119,008 bottles of Itraconazole Capsules (100 mg), a prescription antifungal medication. This recall was initiated because the drug failed dissolution testing, meaning the capsules may not dissolve properly in the body as intended. If the medication does not dissolve correctly, the patient may not receive the full therapeutic dose, which could lead to ineffective treatment of fungal infections. These products were distributed nationwide in 30-count bottles and were manufactured in India.

Risk

The product failed dissolution specifications, which can prevent the active ingredient from being properly absorbed by the body, potentially resulting in under-dosing and the failure of the antifungal treatment.

What You Should Do

  1. Check your prescription bottle of Itraconazole Capsules (100 mg) for NDC number 59746-282-30 and the following lot numbers and expiration dates: Lot IT119008B (Exp 05/2021), Lot IT120001A (Exp 12/2021), or Lot IT120002A (Exp 12/2021).
  2. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you have an affected bottle.
  3. Return any unused capsules from the affected lots to your pharmacy to receive a refund.
  4. Contact Jubilant Cadista Pharmaceuticals, Inc. at their Salisbury, MD location for further instructions regarding this recall.
  5. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare consultation and pharmacy refund

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

Affected Products

Product: Itraconazole Capsules (100 mg, 30-count bottle)
Model:
NDC 59746-282-30
Recall #: D-0333-2021
Lot Numbers:
IT119008B (Exp 05/2021)
IT120001A (Exp 12/2021)
IT120002A (Exp 12/2021)
IT20001A
IT20002B
Date Ranges: Expiration 05/2021, Expiration 12/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87667
Status: Resolved
Manufacturer: Jubilant Cadista Pharmaceuticals, Inc.
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 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 · 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.