The Recall Desk
HighFDA (Drugs)·D-0550-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter

QuVa Pharma is recalling fentanyl and bupivacaine injection bags 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 involves a high-risk injection product where the hazard (glass particulates) poses a direct risk of physical injury, but the source text does not report any specific illnesses or injuries, fitting the 'High' criteria for risk-of-harm products without reported injury.

Plain-English summary

QuVa Pharma, Inc. is recalling specific lots of fentanyl 200 mcg/100 mL and bupivacaine HCl 0.125% in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag. The recall was initiated because the manufacturer recalled the fentanyl active pharmaceutical ingredient (API) due to the potential for glass particles.

The affected product is a prescription medication distributed nationwide. The source text lists numerous lot numbers with expiration dates ranging from November 2019 to January 2020. The hazard is the presence of particulate matter, specifically glass particles, which poses a risk to patients receiving the injection.

Healthcare providers and patients should check their inventory and medication records for the specific lot numbers listed in the official recall notice. If the product is found, it should be quarantined and not administered. For more information, contact QuVa Pharma, Inc. or the FDA.

The recalled product

Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1104-36
Manufacturer
QuVa Pharma, Inc.
Category
Drug — Injectable Anesthetic/Analgesic
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: 1002929 Exp. 11/14/2019
  • 10029839 Exp. 11/19/2019
  • 10029840 Exp. 11/19/2019
  • 10029806 Exp. 11/18/2019
  • 10029860 Exp. 11/18/2019
  • 10030370 Exp. 11/25/2019
  • 10030002 Exp. 11/24/2019
  • 10030001 Exp. 11/25/2019
  • 10030003 Exp. 11/24/2019
  • 10030013 Exp. 11/24/2019
  • 10030014 Exp. 11/24/2019
  • 10030538 Exp. 11/28/2019
  • 10030906 Exp. 11/28/2019
  • 10030905 Exp. 11/28/2019
  • 10030429 Exp. 11/26/2019
  • 10031151 Exp. 12/8/2019
  • 10031039 Exp. 12/5/2019
  • 10031282 Exp. 12/11/2019
  • 10031412 Exp. 12/15/2019
  • 10031432 Exp. 12/16/2019

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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