The Recall Desk
HighFDA (Drugs)·D-0553-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl Infusion Bags Due to Glass Particulates

QuVa Pharma is recalling fentanyl infusion bags because they may contain glass particulates. The affected product is distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medication (fentanyl) with a physical hazard (glass particulates) that poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

QuVa Pharma, Inc. is recalling fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, NDC 70092-1093-37. The recall was initiated due to the presence of particulate matter, specifically the potential for glass particulates in the fentanyl API.

The affected product is distributed nationwide. The recall covers numerous lots with expiration dates ranging from November 2019 to January 2020. The source text does not specify the total number of units affected or report any illnesses or injuries associated with the use of these products.

Healthcare providers and patients should check their inventory and medication records for the specific NDC and lot numbers listed in the official recall notice. If you have questions about this recall, contact QuVa Pharma, Inc. or your healthcare provider for guidance on appropriate actions.

The recalled product

Product
fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37
Manufacturer
QuVa Pharma, Inc.
Category
Drug — Injectable
Hazard

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 (20)

  • Lots: 10029202 Exp. 11/17/2019
  • 10029753 Exp. 11/17/2019
  • 10029756 Exp. 11/17/2019
  • 10029792 Exp. 11/18/2019
  • 10029793 Exp. 11/18/2019
  • 10029808 Exp. 11/18/2019
  • 10029809 Exp. 11/18/2019
  • 10029810 Exp. 11/18/2019
  • 10029757 Exp. 11/17/2019
  • 10029758 Exp. 11/17/2019
  • 10029920 Exp. 11/19/2019
  • 10029897 Exp. 11/20/2019
  • 10030394 Exp. 11/25/2019
  • 10030395 Exp. 11/25/2019
  • 10030479 Exp. 11/27/2019
  • 10030480 Exp. 11/27/2019
  • 10030481 Exp. 11/27/2019
  • 10030449 Exp. 11/26/2019
  • 10030450 Exp. 11/26/2019
  • 10030451 Exp. 11/26/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 27 recalled by QuVa Pharma, 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 27 products in this recall →

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Same hazard · particulate matter

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