The Recall Desk
SevereFDA (Drugs)·D-0549-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl and Bupivacaine IV Bags Due to Particulate Matter

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

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, and the presence of glass particulate matter in an intravenous drug poses a significant risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

QuVa Pharma, Inc. is recalling specific lots of fentanyl 500 mcg/250 mL and bupivacaine HCl 0.0625% in 0.9% Sodium Chloride in 250 mL bags. The recall was initiated because of the presence of particulate matter in the product.

The manufacturer identified the potential cause as glass particles. The affected product is distributed nationwide. The recall covers multiple lots with expiration dates ranging from November 2019 to January 2020.

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

The recalled product

Product
fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37
Manufacturer
QuVa Pharma, Inc.
Category
Drug — IV 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: 10029288 Exp. 11/14/2019
  • 10029762 Exp. 11/14/2019
  • 10029788 Exp. 11/18/2019
  • 10029838 Exp. 11/19/2019
  • 10029948 Exp. 11/21/2019
  • 10029949 Exp. 11/21/2019
  • 10030337 Exp. 11/24/2019
  • 10030539 Exp. 11/28/2019
  • 10030943 Exp. 12/3/2019
  • 10030964 Exp. 12/3/2019
  • 10030963 Exp. 12/3/2019
  • 10030888 Exp. 12/2/2019
  • 10031129 Exp. 12/8/2019
  • 10031284 Exp. 12/11/2019
  • 10031414 Exp. 12/15/2019
  • 10031435 Exp. 12/16/2019
  • 10031735 Exp. 12/22/2019
  • 10032253 Exp. 12/30/2019
  • 10030455 Exp. 11/26/2019
  • 10032535 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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