The Recall Desk
ModerateFDA (Drugs)·D-1571-2014·Announced 2014-10-01

Akorn Recalls Rifampin for Injection Due to Impurity Specification Failure

Akorn, Inc. is recalling 5,539 vials of Rifampin for Injection USP, 600 mg, because a stability test showed an impurity level exceeding specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric associates with scores of 1 or 2. Given the nature of the impurity failure in a sterile injectable, a score of 2 (Moderate) is appropriate as it is a voluntary precautionary recall where adverse health consequences are unlikely but not impossible.

Plain-English summary

Akorn, Inc. is voluntarily recalling 5,539 vials of Rifampin for Injection USP, 600 mg, sterile, for IV infusion only. The product is supplied in sterile glass vials, individually boxed, and is prescription-only. The specific lot affected is 12RIF4A, with an expiration date of 9/30/2014. The product was distributed nationwide.

The recall was initiated because the product failed an impurity/degradation specification. Specifically, a high out-of-specification result was found for the 23 transacetyl impurity at the 22-month stability time point. The U.S. Food and Drug Administration has classified this recall as Class III, which indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences.

Healthcare providers and patients should stop using the affected lot of Rifampin for Injection USP. Consumers and healthcare facilities should contact their pharmacist or the recalling firm, Akorn, Inc., for further instructions on how to return or dispose of the product. No illnesses or injuries have been reported in connection with this recall.

The recalled product

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
Manufacturer
Akorn, Inc.
Category
Drug — Injectable
Hazard
Affected units
5,539

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

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