Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Industries, Inc.: DOXOrubicin Hydrochloride Liposome Injection Recalled for Lack of Sterility

Agency Publication Date: January 19, 2018
Share:
Sign in to monitor this recall

Summary

Approximately 393 vials of DOXOrubicin Hydrochloride Liposome Injection (doxorubicin), 20 mg/10 ml, have been recalled because of a lack of assurance of sterility. This means the manufacturer cannot guarantee the product is free from bacteria or other harmful microorganisms, which is critical for an injectable medication. The affected product is packaged in 10 mL single-use vials and was distributed nationwide in the United States. While no specific injuries or infections have been reported in the provided data, the company has notified customers by letter to address the potential risk.

Risk

If an injectable drug is not sterile, it can introduce contaminants directly into the patient's body, potentially leading to serious or life-threatening systemic infections, such as sepsis.

What You Should Do

  1. Check your medical supplies for DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vials with NDC 47335-049-40.
  2. Verify the specific lot information on the vial label: look for Lot # JKS0403A with an expiration date of February 2019 (02/2019).
  3. If you identify an affected vial, do not use it. Contact your healthcare provider or pharmacist immediately for guidance and to arrange for an alternative supply.
  4. Return any unused product to the place of purchase or pharmacy for a refund and contact Sun Pharmaceutical Industries, Inc. for further instructions regarding the return process.
  5. For additional information or to report a concern, 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

Drug recall guidance

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact Sun Pharmaceutical Industries, Inc. for further instructions.

Affected Products

Product: DOXOrubicin Hydrochloride Liposome Injection (20 mg/10 ml)
Model:
NDC 47335-049-40
Lot Numbers:
JKS0403A (Exp 02/2019)
Date Ranges: Exp 02/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78947
Status: Resolved
Manufacturer: Sun Pharmaceutical Industries, Inc.
Manufactured In: India, United States
Units Affected: 393 vials
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 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.