The Recall Desk
LowFDA (Drugs)·D-1840-2019·Announced 2019-09-04

Akorn Recalls Eptifibatide Injection Vials Due to Fill Volume and Impurity Issues

Akorn, Inc. is recalling 648 vials of Eptifibatide Injection because the fill volume was below specification and a known impurity exceeded limits.

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 648 vials of Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial. The product is identified by Lot # 101107A with an expiration date of 10/19. The recall was initiated because the fill volume was out of specification at 94 mL, which is below the required minimum of 100 mL, and the product failed impurities/degradation specifications due to an out-of-specification result for the known impurity D-aspartic acid.

The affected product was distributed nationwide in the U.S. The FDA 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.

Healthcare providers and patients should discontinue use of the affected vials and contact Akorn, Inc. for further instructions or to arrange for return of the product.

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
648

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 #: 101107A
  • Exp. 10/19.

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 →

Related recalls

Same manufacturer · Akorn, Inc.

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