Recalls / Class III
Class IIID-1571-2014
Product
Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42
- Affected lot / code info
- Lot: 12RIF4A, Expiration Date: 9/30/2014
Why it was recalled
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W. Field Court, Suite 300, N/A, Lake Forest, Illinois 60045
Distribution
- Quantity
- 5,539 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-08-05
- FDA classified
- 2014-09-22
- Posted by FDA
- 2014-10-01
- Terminated
- 2015-05-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1571-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.