RecallDepth
Class III Terminated

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

Company
Akorn, Inc.
Recall Initiated
August 5, 2014
Posted
October 1, 2014
Recall Number
D-1571-2014
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
5,539 vials
Firm Location
Lake Forest, IL, United States

Reason for Recall

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

Distribution

Nationwide

Lot / Code Info

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

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