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

FDA recall notice · announced October 1, 2014 · Akorn

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Notes

Distribution: Nationwide
Lot/code information: Lot: 12RIF4A, Expiration Date: 9/30/2014
Quantity: 5,539 vials
Status: Terminated
Products in this recall event:
- 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 (D-1571-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.