The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1496-2016·Announced 2016-09-14

Teva Recalls Eptifibatide Injection Vials Due to Manufacturing Deviations

Teva North America is voluntarily recalling 14,661 vials of Eptifibatide Injection due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

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 II, which typically involves a reasonable probability of temporary or medically reversible health consequences. The source cites CGMP deviations without reporting specific illnesses or injuries, aligning with a moderate severity rating for a voluntary precautionary recall.

Plain-English summary

Teva North America is voluntarily recalling 14,661 vials of Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single-use vials. The product is manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC. The recall was initiated on June 17, 2016, and was classified as Class II by the FDA.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The affected lots are 2710715, 2720715, 2730715, 3110715, and 3120715. These products were distributed nationwide and in Puerto Rico.

The recall was terminated on February 7, 2017. Patients and healthcare providers should check their inventory for the specific lot numbers listed and contact Teva North America or the FDA for further instructions.

The recalled product

Product
Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.
Manufacturer
Teva North America
Category
Drug — Injection
Hazard
Affected units
14,661

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 (5)

  • All Lots Within Expiry Lot# 2710715
  • 2720715
  • 2730715
  • 3110715
  • 3120715

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Teva North America 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 4 products in this recall →

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