The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1494-2016·Announced 2016-09-14

Teva Recalls Argatroban Injection Due to Manufacturing Deviations

Teva North America is voluntarily recalling 1,299 bags of Argatroban Injection due to Current Good Manufacturing Practice (CGMP) deviations.

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 indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source cites CGMP deviations without reporting specific illnesses or injuries, fitting the Moderate severity criteria for voluntary precautionary recalls.

Plain-English summary

Teva North America is voluntarily recalling 1,299 bags of ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL). The product is a prescription-only medication manufactured in Hungary for Teva Pharmaceuticals USA, Inc. The recall affects specific lots: 4720915, 6790315, 6800315, 6810315, and 6820315, all within their expiry dates.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The affected products were distributed nationwide and in Puerto Rico. The recall was initiated on June 17, 2016, and was terminated on February 7, 2017.

Healthcare providers and patients should check their inventory and records for the specific NDC numbers (0703-0020-31 and 0703-0020-32) and lot numbers listed above. If you have this product, contact your healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).
Manufacturer
Teva North America
Category
Drug — Anticoagulant
Hazard
Affected units
1,299

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 # 4720915
  • 6790315
  • 6800315
  • 6810315
  • 6820315

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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