The Recall Desk
SevereFDA (Drugs)·D-0562-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl and Ropivacaine Bags Due to Glass Particulates

QuVa Pharma is recalling specific lots of fentanyl and ropivacaine injection bags due to the 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a drug with potential particulate contamination is categorized as Severe (Score 4), as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

QuVa Pharma, Inc. is recalling specific lots of fentanyl 400 mcg/200 mL and 0.1% ropivacaine HCl 200 mg/200 mL in 0.9% sodium chloride, 200 mL bags. 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 a prescription medication distributed nationwide. The recall covers numerous lots with expiration dates ranging from November 2019 to January 2020. 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.

Healthcare providers and patients should check their inventory and medication labels against the specific lot numbers listed in the official recall notice. If the product matches the recalled lots, it should be discontinued and returned to the manufacturer or a qualified reverse distributor.

The recalled product

Product
fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37
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 (20)

  • Lots: 10029343 Exp. 11/15/2019
  • 10029344 Exp. 11/15/2019
  • 10029345 Exp. 11/15/2019
  • 10029895 Exp. 11/20/2019
  • 10029918 Exp. 11/20/2019
  • 10029919 Exp. 11/20/2019
  • 10030398 Exp. 11/25/2019
  • 10030399 Exp. 11/25/2019
  • 10030400 Exp. 11/25/2019
  • 10031089 Exp. 12/6/2019
  • 10031059 Exp. 12/5/2019
  • 10031060 Exp. 12/5/2019
  • 10031061 Exp. 12/5/2019
  • 10031326 Exp. 12/12/2019
  • 10031327 Exp. 12/12/2019
  • 10031507 Exp. 12/17/2019
  • 10031480 Exp. 12/19/2019
  • 10031618 Exp. 12/19/2019
  • 10031619 Exp. 12/19/2019
  • 10031672 Exp. 12/20/2019

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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