The Recall Desk
SevereFDA (Drugs)·D-0547-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl and Bupivacaine Bags Due to Particulate Matter

QuVa Pharma is recalling specific lots of fentanyl and bupivacaine injection bags due to the presence of particulate matter, including 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 injectable drug poses a significant risk of serious 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 0.125% bupivacaine HCl 312.5 mg/250 mL in 0.9% Sodium Chloride 250 mL bags. The recall was initiated because of the presence of particulate matter in the product.

The manufacturer identified the cause as a potential for glass particles within the fentanyl API. The affected product is distributed nationwide. The recall covers numerous 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 quarantined and not used. Consumers should contact their healthcare provider for guidance on alternative treatments if they have received this medication.

The recalled product

Product
fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37
Manufacturer
QuVa Pharma, Inc.
Category
Drug — Injectable Medication
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: 10029289 Exp. 11/14/2019 10029841 Exp. 11/19/2019
  • 10029861 Exp. 11/19/2019
  • 10029863 Exp. 11/19/2019
  • 10030008 Exp. 11/24/2019
  • 10029946 Exp. 11/21/2019
  • 10030009 Exp. 11/24/2019
  • 10030010 Exp. 11/24/2019
  • 10030483 Exp. 11/27/2019
  • 10030482 Exp. 11/27/2019
  • 10030958 Exp. 12/3/2019
  • 10030908 Exp. 12/2/2019
  • 10030430 Exp. 11/26/2019
  • 10030989 Exp. 12/4/2019
  • 10030959 Exp. 12/3/2019
  • 10030907 Exp. 12/2/2019
  • 10031283 Exp. 12/11/2019
  • 10031345 Exp. 12/12/2019
  • 10031346 Exp. 12/12/2019
  • 10031477 Exp. 12/16/2019
  • 10031433 Exp. 12/15/2019

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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Same hazard · particulate matter

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