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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

Jubilant Cadista Pharmaceuticals, Inc.: Olanzapine Orally Disintegrating Tablets Recalled for Subpotency

Agency Publication Date: November 5, 2020
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Summary

Jubilant Cadista Pharmaceuticals, Inc. has voluntarily recalled 23,616 blister packs of Olanzapine Orally Disintegrating Tablets (5 mg), a prescription medication used to treat certain mental health conditions. The recall was initiated because the tablets were found to be subpotent, meaning they may not contain the full required amount of the active ingredient. This medication was distributed nationwide in 30-count blister packs (3x10 unit doses). If you have this medication, you should contact your healthcare provider or pharmacist for guidance regarding your treatment.

Risk

The tablets are subpotent, which means they do not meet the required strength specifications. This could result in a patient receiving a lower dose of medication than intended, potentially leading to a lack of effectiveness in managing their medical condition.

What You Should Do

  1. Check your medication packaging for Olanzapine Orally Disintegrating Tablets, 5 mg, in 30-count (3x10 unit dose) blister packs with NDC 59746-0306-32.
  2. Verify if your product belongs to Lot # AE119001A with an expiration date of 01/2021.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if your medication is part of this recall.
  4. Return any unused tablets from the affected lot to your pharmacy for a refund.
  5. Contact Jubilant Cadista Pharmaceuticals, Inc. at their Salisbury, MD location for further instructions regarding this recall.
  6. For additional questions or to report any adverse events, 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

Healthcare provider 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: Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack
Model:
NDC 59746-0306-32
Recall #: D-0066-2021
Lot Numbers:
AE119001A (Exp 01/2021)
Date Ranges: 01/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86658
Status: Resolved
Manufacturer: Jubilant Cadista Pharmaceuticals, Inc.
Sold By: pharmacies nationwide
Manufactured In: United States, India
Units Affected: 23,616 blister packs
Distributed To: Nationwide

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.