The Recall Desk
SevereFDA (Drugs)·D-0554-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl and Ropivacaine Infusions Due to Particulate Matter

QuVa Pharma is recalling specific lots of fentanyl and ropivacaine infusions due to the potential presence of glass particulate matter.

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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or structural defects (glass particulates in an injectable) map to a score of 4 (Severe).

Plain-English summary

QuVa Pharma, Inc. is recalling specific lots of fentanyl 400 mcg/200 mL and ropivacaine HCl 0.2% 400 mg/200 mL in 0.9% Sodium Chloride 200 mL CADD Preservative Free. The recall was initiated because the manufacturer recalled the fentanyl active pharmaceutical ingredient (API) due to the potential for glass particulates.

The affected product is distributed nationwide. The recall covers specific lots with expiration dates ranging from November 2019 to January 2020. The product is a prescription medication intended for use in CADD pumps.

Healthcare providers and patients should discontinue use of the affected lots and contact QuVa Pharma for further instructions or replacements. 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 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride 200 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1440-76
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 (12)

  • Lots: 10029307 Exp. 11/14/2019
  • 10029939 Exp. 11/20/2019
  • 10029884 Exp. 11/19/2019
  • 10029915 Exp. 11/20/2019
  • 10030385 Exp. 11/25/2019
  • 10030386 Exp. 11/25/2019
  • 10030923 Exp. 12/11/2019
  • 10031320 Exp. 12/11/2019
  • 10031025 Exp. 12/12/2019
  • 10031024 Exp. 12/12/2019
  • 10032678 Exp. 1/8/2020
  • 10032993 Exp. 1/14/2020

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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