The Recall Desk
SevereFDA (Drugs)·D-0567-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl Injection Bags Due to Glass Particulates

QuVa Pharma is recalling fentanyl injection bags due to the potential presence of glass particulates.

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, which corresponds to a Severe severity score under the rubric. The presence of glass particulates in an injectable medication poses a significant risk of injury.

Plain-English summary

QuVa Pharma, Inc. is recalling fentanyl 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag 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 multiple lots with expiration dates ranging from November 2019 to January 2020. The specific lot numbers and expiration dates are listed in the structured product information.

Consumers and healthcare providers should check their inventory for the affected NDC 70092-1444-05 and lot numbers. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1444-05
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 (20)

  • Lots: 10029186 Exp. 11/18/2019
  • 10029791 Exp. 11/18/2019
  • 10030403 Exp. 11/25/2019
  • 10030456 Exp. 11/27/2019
  • 10030910 Exp. 12/2/2019
  • 10031154 Exp. 12/8/2019
  • 10031238 Exp. 12/10/2019
  • 10031182 Exp. 12/9/2019
  • 10031130 Exp. 12/8/2019
  • 10031483 Exp. 12/16/2019
  • 10031482 Exp. 12/16/2019
  • 10031621 Exp. 12/19/2019
  • 10031592 Exp. 12/19/2019
  • 10031921 Exp. 12/25/2019
  • 10031869 Exp. 12/24/2019
  • 10032219 Exp. 12/29/2019
  • 10032393 Exp. 1/1/2020
  • 10032369 Exp. 1/1/2020
  • 10032561 Exp. 1/6/2020
  • 10032586 Exp. 1/6/2020

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 particulates

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