Key Takeaway

Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60. by Mylan Laboratories Limited (Sterile Products Division) was recalled on October 7, 2019. The hazard: Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the pro...

FDA Drug Class II Terminated

Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.

Recalled: October 7, 2019 ~19,165 vials units affected D-0139-2020

Description

Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.

Hazard / Reason

Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.

Drugs

Company Information

Mylan Laboratories Limited (Sterile Products Division)

Bangalore, N/A, India

View all 1 recalls by Mylan Laboratories Limited (Sterile Products Division) →

Distribution

Nationwide in the USA

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.