D-1571-2014 Class III Terminated
FDA drug recall D-1571-2014 was initiated by Akorn, Inc. on Aug 5, 2014 and is designated Class III. Reason for recall: Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point The recall status is terminated (terminated May 21, 2015). Affected quantity: 5,539 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 1, 2014
- Initiation Date
- Aug 5, 2014
- Termination Date
- May 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,539 vials
Product Description
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
Reason for Recall
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Distribution Pattern
Nationwide
Code Information
Lot: 12RIF4A, Expiration Date: 9/30/2014
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1571-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026