The Recall Desk
SevereFDA (Drugs)·D-0568-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl and Bupivacaine Infusion Due to Glass Particulates

QuVa Pharma is recalling specific lots of a fentanyl and bupivacaine infusion due to the 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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury reports or structural defects are rated Severe (4). While specific injury reports are not detailed in the text, the presence of glass particulates in an IV infusion is a significant hazard that fits the Severe criteria for Class II drug recalls.

Plain-English summary

QuVa Pharma, Inc. is recalling specific lots of fentanyl and bupivacaine hydrochloride infusion in 0.9% sodium chloride. The recall was initiated because of the presence of particulate matter, specifically the potential for glass particulates in the product.

The affected product is a preservative-free, prescription medication distributed nationwide. The recall covers nine specific lots with expiration dates ranging from November 2019 to January 2020. The product is identified by NDC 70092-1436-76.

Healthcare providers and patients should stop using the affected lots and contact QuVa Pharma or their local FDA office for further instructions. The FDA has classified 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 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
Manufacturer
QuVa Pharma, Inc.
Category
Drug — Infusion
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: 10029972 Exp. 11/21/2019
  • 10030562 Exp. 11/28/2019
  • 10031447 Exp. 12/15/2019
  • 10031341 Exp. 12/15/2019
  • 10031630 Exp. 12/19/2019
  • 10031748 Exp. 12/22/2019
  • 10032817 Exp. 1/8/2020
  • 10033208 Exp. 1/19/2020
  • 10032887 Exp. 1/12/2020

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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