The Recall Desk
HighFDA (Drugs)·D-0566-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter

QuVa Pharma is recalling specific lots of fentanyl syringes because they may contain glass particulate matter.

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 specific injuries or illnesses, aligning with 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 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free. The recall is due to the presence of particulate matter, specifically the potential for glass particles in the fentanyl API.

The affected product is identified by NDC 70092-1415-47. The recall includes the following lots: 10030359 (Exp. 11/21/2019), 10030549 (Exp. 11/28/2019), 10031169 (Exp. 12/8/2019), 10031491 (Exp. 12/16/2019), 10031879 (Exp. 12/24/2019), 10032317 (Exp. 12/31/2019), and 10032265 (Exp. 12/30/2019). The product was distributed nationwide.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or supplier for replacement or refund.

The recalled product

Product
fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1415-47
Manufacturer
QuVa Pharma, Inc.
Category
Drug — Injectable Medication
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 (7)

  • Lots: 10030359 Exp. 11/21/2019
  • 10030549 Exp. 11/28/2019
  • 10031169 Exp. 12/8/2019
  • 10031491 Exp. 12/16/2019
  • 10031879 Exp. 12/24/2019
  • 10032317 Exp. 12/31/2019
  • 10032265 Exp. 12/30/2019

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 →

Related recalls

Same manufacturer · QuVa Pharma, Inc.

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Same hazard · glass particulate

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