The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1839-2019·Announced 2019-09-04

Akorn Recalls Eptifibatide Injection Vials Due to Impurity

Akorn, Inc. is recalling 4,085 vials of Eptifibatide Injection because they failed impurity specifications for D-aspartic acid.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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

Our severity reasoning: The FDA classified this recall as Class III, 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 4,085 vials of Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial. The product is for intravenous use only and is available by prescription. The recall affects Lot #s 091287A and 091377A, which have an expiration date of 9/19.

The recall was initiated because the product failed impurities/degradation specifications, specifically testing out of specification (OOS) for the known impurity D-aspartic acid. The affected vials were distributed nationwide in the U.S.

Healthcare providers and patients should stop using the recalled product and contact Akorn, Inc. or their supplier for further instructions. The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product
Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90.
Manufacturer
Akorn, Inc.
Category
Drug — Injectable
Hazard
Affected units
4,085

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 (3)

  • Lot #s: 091287A
  • 091377A
  • Exp. 9/19.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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