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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

Mylan Laboratories Limited (Sterile Products Division): Rifampin for Injection Recalled for Impurities and Discoloration

Agency Publication Date: October 15, 2019
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Summary

Mylan Institutional LLC is recalling 19,165 vials of Rifampin for Injection, USP (600 mg/vial). This prescription antibiotic was found to have discoloration caused by elevated levels of an unknown impurity that failed quality specifications. This chemical degradation can decrease the effectiveness of the medication, potentially failing to treat the underlying infection as intended. Consumers should contact their healthcare provider or pharmacist for guidance on alternative treatments and return any unused product to their pharmacy for a refund.

Risk

The presence of elevated impurities indicates the drug is degrading, which can reduce the potency and effectiveness of the antibiotic treatment. If the medication does not work correctly, the patient's infection may not be properly treated, leading to worsened health outcomes.

What You Should Do

  1. Check your medication packaging for Rifampin for Injection, USP, 600 mg/vial with NDC 67457-445-60.
  2. Identify if your product is from the affected lots: Lot 7008334 (Expiration April 2020) or Lot 7008417 (Expiration October 2020).
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment if you have one of these affected lots.
  4. Return any unused vials of the recalled medication to the pharmacy or place of purchase for a refund.
  5. Contact Mylan Laboratories Limited if you have further questions regarding this recall.
  6. For additional information, 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

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: Rifampin for Injection, USP (600 mg/vial)
Model:
NDC 67457-445-60
Lot Numbers:
7008334 (Exp April 2020)
7008417 (Exp Oct 2020)
Date Ranges: April 2020, October 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83914
Status: Resolved
Manufacturer: Mylan Laboratories Limited (Sterile Products Division)
Sold By: hospitals; clinics; pharmacies
Manufactured In: India
Units Affected: 19,165 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 · 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.