D-0231-2016 Class III Terminated
FDA drug recall D-0231-2016 was initiated by Akorn, Inc. on Aug 20, 2015 and is designated Class III. Reason for recall: Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity. The recall status is terminated (terminated Jan 26, 2017). Affected quantity: 6861 Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 25, 2015
- Initiation Date
- Aug 20, 2015
- Termination Date
- Jan 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6861 Vials
Product Description
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Reason for Recall
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Distribution Pattern
US: Nationwide
Code Information
Lot #: 14RIF1(A), Expiry: 9/30/2016.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0231-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026