FDA-Drug2014-10-01Class III

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

Akorn, Inc.
Hazard

Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point

Sold states
Nationwide
Affected count
5,539 vials
Manufactured in
1925 W. Field Court, Suite 300, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1571-2014

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