The Recall Desk
HighFDA (Drugs)·D-0560-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter

QuVa Pharma is recalling fentanyl 250 mcg/5 mL syringes due to the presence of glass particulate matter. The recall is 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 is classified as FDA Class II, and the hazard involves particulate matter (glass) in an injectable medication, which poses a risk of harm even without reported injuries.

Plain-English summary

QuVa Pharma, Inc. is recalling fentanyl 250 mcg/5 mL (50 mcg/mL) 5 mL syringes, preservative-free, prescription only. The recall was initiated because of the presence of particulate matter, specifically due to the potential for glass particles in the product.

The affected product is identified by NDC 70092-1098-44. The recall includes specific lots with expiration dates ranging from November 2019 to December 2019. The distribution pattern for these products is nationwide.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the supplier or the manufacturer as directed by the recall firm.

The recalled product

Product
fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1098-44
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 (6)

  • Lots: 10030458 Exp. 11/26/2019
  • 10031113 Exp. 12/5/2019
  • 10031305 Exp. 12/11/2019
  • 10031417 Exp. 12/15/2019
  • 10031765 Exp. 12/26/2019
  • 10032259 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 →

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Same manufacturer · QuVa Pharma, Inc.

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Same hazard · particulate matter

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