Recalls / Class III
Class IIID-0231-2016
Product
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
- Affected lot / code info
- Lot #: 14RIF1(A), Expiry: 9/30/2016.
Why it was recalled
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
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
- 6861 Vials
- Distribution pattern
- US: Nationwide
Timeline
- Recall initiated
- 2015-08-20
- FDA classified
- 2015-11-13
- Posted by FDA
- 2015-11-25
- Terminated
- 2017-01-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0231-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.