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Recall Observatory FDA recall evidence

Drug 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

D-1571-2014

August 05, 2014

Class III

Product summary

Firm
Akorn, Inc.
Event
Event 69013
Status
Terminated
Classification
Class III
Quantity
5,539 vials
Official record key
drug-enforcement:D-1571-2014

Official wording

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

Code information: Lot: 12RIF4A, Expiration Date: 9/30/2014

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification