FDAClass IIIOctober 1, 2014

Rifampin for Injection USP recall: Impurity Out of Spec

Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for…

Why was Rifampin for Injection USP recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for…
Recalling firm
Akorn, Inc.
Quantity
5,539 vials
Distribution
Nationwide
Recall date
October 1, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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