The Recall Desk
SevereFDA (Drugs)·D-0559-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl and Bupivacaine Infusions Due to Particulate Matter

QuVa Pharma is recalling specific lots of fentanyl and bupivacaine infusions 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential physical contamination like particulate matter in injectable drugs.

Plain-English summary

QuVa Pharma, Inc. is recalling specific lots of fentanyl 200 mcg/100 mL and bupivacaine HCl 0.1% in 0.9% Sodium Chloride 100 mL CADD 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 a prescription medication distributed nationwide. The recall covers multiple lots with expiration dates ranging from November 20, 2019, to January 15, 2020. The specific lot numbers and expiration dates are listed in the structured product information.

Healthcare providers and patients should stop using the affected lots and contact QuVa Pharma or their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating a situation where 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) BUPivacaine HCl 0.1% 100 mg/100 mL (1 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 70092-1255-75
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: 10029914 Exp. 11/20/2019
  • 10030342 Exp. 11/24/2019
  • 10030948 Exp. 12/3/2019
  • 10030895 Exp. 12/2/2019
  • 10030949 Exp. 12/3/2019
  • 10031377 Exp. 12/6/2019
  • 10031141 Exp. 12/9/2019
  • 10031423 Exp. 12/15/2019
  • 10031627 Exp. 12/19/2019
  • 10031709 Exp. 12/22/2019
  • 10031907 Exp. 12/25/2019
  • 10032022 Exp. 12/27/2019
  • 10031858 Exp. 12/24/2019
  • 10032381 Exp. 1/1/2020
  • 10032296 Exp. 12/31/2019
  • 10032268 Exp. 12/30/2019
  • 10032467 Exp. 1/2/2020
  • 10032674 Exp. 1/8/2020
  • 10032569 Exp. 1/6/2020
  • 10032570 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 →

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Same hazard · particulate matter

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