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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

Shilpa Medicare Limited: Various Oncology and Chronic Condition Medications Recalled for Manufacturing Issues

Agency Publication Date: December 9, 2020
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Summary

Shilpa Medicare Limited is recalling over 53,000 units of several prescription medications, including Busulfan, Azacitidine, Imatinib Mesylate, and Docetaxel, due to deviations from Current Good Manufacturing Practice (CGMP) standards. These drugs are used to treat various types of cancer and other serious conditions and were distributed nationwide to pharmacies and healthcare facilities. Because these products did not meet strict quality control standards during production, their safety and effectiveness cannot be guaranteed.

Risk

The manufacturing deviations could result in products that do not meet their required quality specifications, which may lead to ineffective treatment or unexpected side effects for patients using these critical medications.

What You Should Do

  1. Check your medication packaging for the following identifying details: Busulfan Injection (Lot 7S10008B), Azacitidine for Injection (Lots 7S10115A, 7S10143A, 7S10182B, 7S10255A, 7S10256A, 7S10263A, 7T10028A, 7T10040A, or 7S10227A), Imatinib Mesylate Tablets (Lots 7S10033B, 7S10033A, 7S10031A, 7S10032A, or 7S10034A), or Docetaxel Injection (Lot 7S10185A).
  2. Verify the NDC numbers on your medication labels against the affected list: Busulfan (NDC 72485-210-01, 72485-210-08), Azacitidine (72485-201-01, 72606-558-01), Imatinib (72485-202-90, 72485-203-30), and Docetaxel (72485-216-08).
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if your specific supply is affected.
  4. Return any unused recalled medication to your pharmacy to receive a refund and to ensure the product is disposed of correctly.
  5. Contact Shilpa Medicare Limited or the distributor, Armas Pharmaceuticals, 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

💰Full Refund

Refund for unused product

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

Affected Products

Product: Busulfan Injection 60 mg/10 mL (6 mg/mL)
Model:
NDC 72485-210-01
NDC 72485-210-08
Lot Numbers:
7S10008B (Exp. 12/31/2020)
Date Ranges: 12/31/2020
Product: Azacitidine for Injection 100 mg/vial (Armas NDC 72485-201-01)
Model:
NDC 72485-201-01
Lot Numbers:
7S10115A (Exp. 07/31/2021)
7S10143A (Exp. 09/30/2021)
7S10182B (Exp. 09/30/2021)
7S10255A (Exp. 11/30/2021)
7S10256A (Exp. 11/30/2021)
7S10263A (Exp. 11/30/2021)
7T10028A (Exp. 12/31/2021)
7T10040A (Exp. 01/31/2022)
Date Ranges: 07/31/2021 - 01/31/2022
Product: Azacitidine for Injection 100 mg/vial (NDC 72606-558-01)
Model:
NDC 72606-558-01
Lot Numbers:
7S10227A (Exp. 10/31/2021)
Date Ranges: 10/31/2021
Product: Imatinib Mesylate Tablets 100 mg (90-count Bottle)
Model:
NDC 72485-202-90
Lot Numbers:
7S10033B (Exp. 02/28/2021)
7S10033A (Exp. 02/28/2021)
7S10031A (Exp. 02/28/2021)
Date Ranges: 02/28/2021
Product: Imatinib Mesylate Tablets 400 mg (30-count Bottle)
Model:
NDC 72485-203-30
Lot Numbers:
7S10032A (Exp. 02/28/2021)
7S10034A (Exp. 02/28/2021)
Date Ranges: 02/28/2021
Product: Docetaxel Injection USP 160 mg/8mL (20 mg/mL)
Model:
NDC 72485-216-08
Lot Numbers:
7S10185A (Exp. 10/31/2021)
Date Ranges: 10/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86749
Status: Resolved
Manufacturer: Shilpa Medicare Limited
Sold By: Armas Pharmaceuticals, Inc.; pharmacies; hospitals
Manufactured In: India
Units Affected: 6 products (2,064 vials; 35,931 vials; 6,560 vials; 2611 bottles; 4166 bottles; 2008 vials)
Distributed To: Nationwide
Agency Last Updated: January 22, 2021

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.