The Recall Desk
SevereFDA (Drugs)·D-0570-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl PCA Vials Due to Glass Particulate Matter

QuVa Pharma is recalling specific lots of fentanyl PCA vials 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, which corresponds to a Severe rating under the rubric, particularly given the risk of glass particulate matter in an injectable medication.

Plain-English summary

QuVa Pharma, Inc. is recalling fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vials, Preservative Free. The recall is being conducted 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 70092-1180-79. The recall covers specific lots with expiration dates ranging from November 2019 to December 2019. The distribution pattern for these products was nationwide.

Healthcare providers and patients should check their inventory and medication supplies for the specific lot numbers listed in the recall notice. If the product is found, it should be discontinued and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product
fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1180-79
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 (9)

  • Lots: 10030060 Exp. 11/21/2019
  • 10030574 Exp. 11/28/2019
  • 10031353 Exp. 12/12/2019
  • 10031677 Exp. 12/20/2019
  • 10031622 Exp. 12/19/2019
  • 10031419 Exp. 12/15/2019
  • 10031769 Exp. 12/26/2019
  • 10031826 Exp. 12/23/2019
  • 10032287 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 →

Related recalls

Same manufacturer · QuVa Pharma, Inc.

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Same hazard · glass particulate

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