FDAFDA · Food and drugs·Recall number D-1571-2014
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
Published October 1, 2014 · Recall initiated: August 5, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide
- Lot
- Lot: 12RIF4A, Expiration Date: 9/30/2014
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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