The Recall Desk
SevereFDA (Drugs)·D-0565-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter

QuVa Pharma is recalling specific lots of fentanyl and bupivacaine injection 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is mapped to a score of 4 (Severe).

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 Preservative Free 100 mL in 150 mL Bag. The recall was initiated because of the presence of particulate matter, specifically due to the potential for glass particles in the product.

The affected product is a prescription (Rx) medication manufactured by QuVa Pharma, Inc., located in Sugar Land, Texas. The recall covers eight specific lots with expiration dates ranging from November 18, 2019, to December 30, 2019. The distribution pattern for these products was nationwide.

Healthcare providers and patients should stop using the affected lots immediately. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 Preservative Free 100 mL in 150 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1103-36
Manufacturer
QuVa Pharma, Inc.
Category
Drug — Injectable Anesthetic
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 (8)

  • Lots: 10029200 Exp. 11/18/2019
  • 10030347 Exp. 11/24/2019
  • 10031325 Exp. 12/16/2019
  • 10030939 Exp. 12/3/2019
  • 10031865 Exp. 12/24/2019
  • 10031758 Exp. 12/26/2019
  • 10031757 Exp. 12/26/2019
  • 10032275 Exp. 12/30/2019

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

Same manufacturer · QuVa Pharma, Inc.

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Same hazard · particulate matter

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