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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 Rifampin for Injection Recalled for Impurities and Stability Issues

Agency Publication Date: April 15, 2022
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Summary

Mylan Pharmaceuticals Inc. is recalling 33,893 vials of Rifampin for Injection, USP (600 mg/vial), an injectable antibiotic used to treat bacterial infections. The recall was issued after stability testing revealed that levels of a drug-related compound exceeded approved specifications, indicating the product is degrading faster than expected. While no incidents or injuries have been reported, the medication was distributed nationwide to hospitals and pharmacies.

Risk

The use of the affected medication may expose patients to higher-than-expected levels of drug impurities. This degradation can reduce the effectiveness of the antibiotic treatment or potentially cause unknown adverse health effects.

What You Should Do

  1. This recall affects Rifampin for Injection, USP, 600 mg/vial, packaged as one vial per carton (NDC 67457-445-60) manufactured for Mylan Institutional LLC.
  2. Check your inventory for the following lot numbers and expiration dates: Lot 7008990 (Exp Dec-2022), Lot 7009025 (Exp Feb-2023), Lot 7009085 (Exp Apr-2023), and Lot 7009086 (Exp Apr-2023).
  3. Stop using the recalled product immediately.
  4. Contact Mylan Pharmaceuticals Inc. or your drug distributor to arrange for the return of any remaining vials from these affected lots.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action

Hospital/Clinical return

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Rifampin for Injection, USP (600 mg/vial)
Variants: 600 mg/vial, One Vial per carton, Rx only
Lot Numbers:
7008990 (Exp Dec-2022)
7009025 (Exp Feb-2023)
7009085 (Exp Apr-2023)
7009086 (Exp Apr-2023)
NDC:
67457-445-60

Manufactured for Mylan Institutional LLC, Morgantown, WV

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89910
Status: Resolved
Manufacturer: Mylan Pharmaceuticals Inc
Sold By: hospitals; pharmacies
Manufactured In: United States
Units Affected: 33,893 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.