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
Reported: October 1, 2014 Initiated: August 5, 2014 #D-1571-2014
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
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 5,539 vials
- Distribution
- Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn, Inc.. Units affected: 5,539 vials.
Why was this product recalled? ▼
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 1, 2014. Severity: Low. Recall number: D-1571-2014.
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