Drug product
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
D-0231-2016
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 72192
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6861 Vials
- Official record key
drug-enforcement:D-0231-2016
Official wording
Reason: Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Code information: Lot #: 14RIF1(A), Expiry: 9/30/2016.
Distribution pattern: US: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specifications