Recalls / Class II
Class IID-0139-2020
Product
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
- Brand name
- Rifampin
- Generic name
- Rifampin
- Active ingredient
- Rifampin
- Route
- Intravenous
- NDC
- 67457-445
- FDA application
- ANDA065421
- Affected lot / code info
- Lot: 7008334, Exp April 2020; 7008417, Exp Oct 2020
Why it was recalled
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Recalling firm
- Firm
- Mylan Laboratories Limited (Sterile Products Division)
- Manufacturer
- Mylan Institutional LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Opp. Iim-B, Bilekahalli , Bannerghatta Road, N/A, Bangalore, N/A N/A, India
Distribution
- Quantity
- 19,165 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-10-07
- FDA classified
- 2019-10-10
- Posted by FDA
- 2019-10-16
- Terminated
- 2023-03-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0139-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.