The Recall Desk
SevereFDA (Drugs)·D-0551-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter

QuVa Pharma is recalling fentanyl syringes due to the potential presence of glass particulate matter. The recall is classified as FDA Class II.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential physical contamination like glass particulates in injectable medications.

Plain-English summary

QuVa Pharma, Inc. is recalling fentanyl 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free. The recall was initiated because the manufacturer recalled the fentanyl active pharmaceutical ingredient (API) due to the potential for glass particulates.

The affected product is distributed nationwide. The recall includes specific lots with expiration dates ranging from November 18, 2019, to December 31, 2019. The FDA has classified this recall as Class II.

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 distributor or manufacturer according to standard recall procedures.

The recalled product

Product
fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1099-49
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 (18)

  • Lots: 10029934 Exp. 11/19/2019
  • 10029820 Exp. 11/18/2019
  • 10029872 Exp. 11/19/2019
  • 10029873 Exp. 11/19/2019
  • 10030868 Exp. 11/28/2019
  • 10030567 Exp. 11/28/2019
  • 10030892 Exp. 12/2/2019
  • 10030568 Exp. 11/28/2019
  • 10031210 Exp. 12/9/2019
  • 10031211 Exp. 12/9/2019
  • 10031209 Exp. 12/12/2019
  • 10031439 Exp. 12/15/2019
  • 10031700 Exp. 12/22/2019
  • 10031438 Exp. 12/15/2019
  • 10031766 Exp. 12/26/2019
  • 10032225 Exp.12/29/2019
  • 10032260 Exp. 12/30/2019
  • 10032343 Exp. 12/31/2019

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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