Drug 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
D-1571-2014
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 69013
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,539 vials
- Official record key
drug-enforcement:D-1571-2014
Official wording
Reason: Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Code information: Lot: 12RIF4A, Expiration Date: 9/30/2014
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification