The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1841-2019·Announced 2019-09-04

Akorn Recalls Eptifibatide Injection Vials Due to Impurity

Akorn, Inc. is recalling Eptifibatide Injection vials 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 Eptifibatide Injection, a prescription medication for intravenous use. The recall involves 8,187 vials of two specific presentations: 20 mg/10 mL (NDC 17478-902-10) and 200 mg/100 mL (NDC 17478-902-90). The affected lots are 091307A, 101097A, and 091277A, all with expiration dates in September or October 2019.

The recall was initiated because the product failed impurity/degradation specifications, specifically testing out of specification for the known impurity D-aspartic acid. 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.

The affected product was distributed nationwide in the U.S. Healthcare providers and pharmacies should discontinue use of the affected lots and contact Akorn, Inc. for further instructions or returns.

The recalled product

Product
Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.
Manufacturer
Akorn, Inc.
Category
Drug — Injection
Hazard
Affected units
8,187

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 (6)

  • Lot #s: a) 091307A
  • Exp. 9/19
  • 101097A
  • Exp. 10/19
  • b) 091277A
  • 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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