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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

InvaGen Pharmaceuticals, Inc.: Decitabine for Injection Recalled Due to Failed Impurity Specifications

Agency Publication Date: April 12, 2018
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Summary

InvaGen Pharmaceuticals is recalling 3,222 vials of Decitabine for Injection (50mg per vial), a prescription chemotherapy medication. The recall was initiated because the product failed quality specifications regarding water content and impurities, which can occur as the drug degrades over time. Consumers who have this medication should not use affected vials and should immediately consult their healthcare provider for guidance on alternative treatments.

Risk

The presence of excessive moisture or impurities indicates the drug may have degraded, potentially reducing its effectiveness or causing unpredictable side effects during treatment. While no specific injuries were reported, using a degraded chemotherapy drug may compromise the intended medical treatment for the patient.

What You Should Do

  1. Check your medication packaging for Decitabine for Injection, 50mg per vial, with NDC number 69097-285-37.
  2. Verify if your product belongs to the affected lots: GE70493, GE70502, or GE70512 with an expiration date of 8/2019.
  3. Immediately contact your healthcare provider or pharmacist if you find you have any of the affected vials to discuss your treatment plan.
  4. Return any unused vials from the affected lots to the pharmacy where they were purchased for a refund.
  5. Contact InvaGen Pharmaceuticals or Cipla USA 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

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: Decitabine for Injection (50mg per vial)
Model:
NDC 69097-285-37
Lot Numbers:
GE70493 (Exp 8/2019)
GE70502 (Exp 8/2019)
GE70512 (Exp 8/2019)
Date Ranges: Expiration 8/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79729
Status: Resolved
Manufacturer: InvaGen Pharmaceuticals, Inc.
Sold By: pharmacies; hospitals
Manufactured In: India, United States
Units Affected: 3222 vials
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.