Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
Reported: October 16, 2019 Initiated: October 7, 2019 #D-0139-2020
Product Description
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
Reason for Recall
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Details
- Recalling Firm
- Mylan Laboratories Limited (Sterile Products Division)
- Units Affected
- 19,165 vials
- Distribution
- Nationwide in the USA
- Location
- Bangalore, N/A
Frequently Asked Questions
What product was recalled? ▼
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.. Recalled by Mylan Laboratories Limited (Sterile Products Division). Units affected: 19,165 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 16, 2019. Severity: Moderate. Recall number: D-0139-2020.
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