Recalls / Class II
Class IID-1234-2015
Product
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20
- Brand name
- Rifampin
- Generic name
- Rifampin
- Active ingredient
- Rifampin
- Route
- Intravenous
- NDC
- 63323-351
- FDA application
- ANDA091181
- Affected lot / code info
- Lot #: 6109469, 6109470, Exp 10/2016
Why it was recalled
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 7,593 vials
- Distribution pattern
- Nationwide,Hawaii, and Puerto Rico
Timeline
- Recall initiated
- 2015-06-04
- FDA classified
- 2015-07-14
- Posted by FDA
- 2015-07-22
- Terminated
- 2016-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1234-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.