FDAClass IIINovember 25, 2015

Rifampin for Injection USP recall: Impurity Out of Spec

RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.

Why was Rifampin for Injection USP recalled?

Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.

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 #: 14RIF1(A), Expiry: 9/30/2016.

Product
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Recalling firm
Akorn, Inc.
Quantity
6861 Vials
Distribution
US: Nationwide
Recall date
November 25, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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