The Recall Desk
LowFDA (Drugs)·D-0231-2016·Announced 2015-11-25

Akorn Recalls RIFAMPIN FOR INJECTION Due to Impurity Specifications

Akorn, Inc. is recalling 6,861 vials of RIFAMPIN FOR INJECTION USP, 600 mg because a known impurity failed to meet specifications.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Akorn, Inc. is recalling 6,861 vials of RIFAMPIN FOR INJECTION USP, 600 mg (NDC: 17478-151-42). The recall affects Lot # 14RIF1(A) with an expiration date of 9/30/2016. The product was distributed nationwide in the United States.

The recall was initiated because the product failed impurity/degradation specifications, specifically obtaining an out-of-specifications result for a known impurity. The U.S. Food and Drug Administration has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.

Healthcare providers and patients should stop using the affected lot of RIFAMPIN FOR INJECTION USP and contact their pharmacist or the manufacturer for further instructions.

The recalled product

Product
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Manufacturer
Akorn, Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
6,861

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 #: 14RIF1(A)
  • Expiry: 9/30/2016.

Distribution

Distributed nationwide across the United States.

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