The Recall Desk
HighFDA (Drugs)·D-0557-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter

QuVa Pharma is recalling fentanyl and bupivacaine injection products due to the presence of particulate matter, specifically potential glass particles.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves particulate matter (glass) in an injectable drug, which poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

QuVa Pharma, Inc. is recalling specific lots of fentanyl 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD 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 distributed nationwide. The recall covers 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 provided by the FDA.

Consumers and healthcare providers should stop using the affected lots immediately and contact QuVa Pharma or their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/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 70092-1202-75
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: 10029306 Exp. 11/14/2019
  • 10029881 Exp. 11/18/2019
  • 10029748 Exp. 11/17/2019
  • 10029882 Exp. 11/18/2019
  • 10029854 Exp. 11/19/2019
  • 10030947 Exp. 12/3/2019
  • 10030894 Exp. 12/2/2019
  • 10030442 Exp. 11/26/2019
  • 10031295 Exp. 12/11/2019
  • 10031319 Exp. 12/11/2019
  • 10031518 Exp. 12/17/2019
  • 10031553 Exp. 12/17/2019
  • 10031468 Exp. 12/16/2019
  • 10032703 Exp. 1/8/2020
  • 10032594 Exp. 1/6/2020
  • 10032543 Exp. 1/5/2020
  • 10031906 Exp. 12/25/2019
  • 10031882 Exp. 12/24/2019
  • 10031802 Exp. 12/23/2019
  • 10031775 Exp. 12/22/2019

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 →

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