Recalls / Class II
Class IID-0774-2022
Product
Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., 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 #: 7008990, exp. date Dec-2022; 7009025, exp. date Feb-2023; 7009085, 7009086, exp. date Apr-2023
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc
- Manufacturer
- Mylan Institutional LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3711 Collins Ferry Rd, Morgantown, West Virginia 26505-2362
Distribution
- Quantity
- 33,893 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-04-07
- FDA classified
- 2022-04-15
- Posted by FDA
- 2022-04-27
- Terminated
- 2023-05-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0774-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.