The Recall Desk
SevereFDA (Drugs)·D-0546-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl and Bupivacaine Bags 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

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, which corresponds to a Severe severity score under the rubric. The presence of glass particulate matter in an injectable drug presents a significant risk of injury.

Plain-English summary

QuVa Pharma, Inc. is recalling specific lots of fentanyl 500 mcg/250 mL and Bupivacaine HCl 0.1% 250 mg/250 mL in 0.9% Sodium Chloride 250 mL bags. 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-only medication distributed nationwide. The recall covers numerous lots with expiration dates ranging from November 2019 to January 2020. The specific hazard identified is the presence of particulate matter, specifically glass particles, which poses a risk to patients receiving the injection.

Healthcare providers and patients should discontinue use of the affected lots and contact QuVa Pharma for further instructions or replacements. Consumers should check their medication packaging for the lot numbers and expiration dates listed in the official recall notice to determine if their product is affected.

The recalled product

Product
fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37
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: 10029297 Exp. 11/14/2019 10029199 Exp. 11/17/2019
  • 10029737 Exp. 11/17/2019
  • 10029763 Exp. 11/17/2019
  • 10029785 Exp. 11/18/2019
  • 10029789 Exp. 11/18/2019
  • 10029790 Exp. 11/18/2019
  • 10029894 Exp. 11/20/2019
  • 10029950 Exp. 11/21/2019
  • 10030006 Exp. 11/24/2019
  • 10030007 Exp. 11/27/2019
  • 10030336 Exp. 11/27/2019
  • 10030941 Exp. 12/3/2019
  • 10030886 Exp. 12/2/2019
  • 10030453 Exp. 11/26/2019
  • 10030887 Exp. 12/4/2019
  • 10030990 Exp. 12/4/2019
  • 10030991 Exp. 12/4/2019
  • 10030942 Exp. 12/3/2019
  • 10030909 Exp. 12/2/2019
  • 10030431 Exp. 11/26/2019

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 →

Related recalls

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Same hazard · particulate matter

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