The Recall Desk
SevereFDA (Drugs)·D-0571-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl Infusions Due to Glass Particulate Matter

QuVa Pharma is recalling specific lots of fentanyl infusion solutions due to the potential presence of glass particulate matter.

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. The presence of glass particulate matter in an intravenous infusion solution poses a significant risk of serious injury, meeting the criteria for a Severe rating.

Plain-English summary

QuVa Pharma, Inc. is recalling fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free. The recall is being conducted because the manufacturer identified a potential for glass particules in the fentanyl API.

The affected product is distributed nationwide. The recall includes specific lots with expiration dates ranging from December 2019 to January 2020. The NDC for the product is 70092-1250-75.

Healthcare providers and patients should discontinue use of the affected lots and contact QuVa Pharma for further instructions or replacements.

The recalled product

Product
fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1250-75
Manufacturer
QuVa Pharma, Inc.
Category
Drug — Infusion Solution
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 (12)

  • Lots: 10030341 11/24/2019
  • 10031102 12/6/2019
  • 10031555 Exp. 12/18/2019
  • 10031554 Exp. 12/18/2019
  • 10031803 Exp. 12/23/2019
  • 10031776 Exp. 12/22/2019
  • 10032266 Exp. 12/30/2019
  • 10032267 Exp. 12/30/2019
  • 10032321 Exp. 12/31/2019
  • 10032320 Exp. 12/31/2019
  • 10032544 Exp. 1/5/2020
  • 10032515 Exp. 1/5/2020

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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