Reported Oct 1, 2014 · Terminated
Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only,…
Akorn, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 1925 W. Field Court, Suite 300 · Lake Forest, IL · 60045
Is this the product you have?
- Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd
- forAkorn, Inc., Lake Forest, IL --- NDC 17478-151-42
- Lot codes and dates
- Lot12RIF4A
- Expiration Date9/30/2014
- Amount recalled
- 5,539 vials
Where it was sold
- Nationwide
Why it was recalled
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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