The Recall Desk
SevereFDA (Drugs)·D-0563-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl Infusion Bags Due to Glass Particulate Matter

QuVa Pharma is recalling specific lots of fentanyl infusion bags due to the 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, and the presence of glass particulate matter in an intravenous medication poses a significant risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

QuVa Pharma, Inc. is recalling specific lots of fentanyl 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free. 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 70092-1094-36. The recall covers multiple lots with expiration dates ranging from November 17, 2019, to January 12, 2020. The distribution pattern for these products was nationwide.

Healthcare providers and patients should check their inventory and medication records for the specific lot numbers listed in the recall notice. If the product is found, it should be quarantined and not administered. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions.

The recalled product

Product
fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1094-36
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 (19)

  • Lots: 10029201 Exp. 11/17/2019
  • 10029983 Exp. 11/22/2019
  • 10029987 Exp. 11/22/2019
  • 10030428 Exp. 11/26/2019
  • 10030879 Exp. 11/28/2019
  • 10031240 Exp. 12/10/2019
  • 10031241 Exp. 12/10/2019
  • 10031344 Exp. 12/12/2019
  • 10031343 Exp. 12/12/2019
  • 10031394 Exp. 12/12/2019
  • 10031612 Exp. 12/19/2019
  • 10031665 Exp. 12/20/2019
  • 10031666 Exp. 12/20/2019
  • 10031590 Exp. 12/18/2019
  • 10031787 Exp. 12/23/2019
  • 10032036 Exp. 12/27/2019
  • 10032305 Exp. 12/31/2019
  • 10032444 Exp. 1/2/2020
  • 10033172 Exp. 1/12/2020

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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