The Recall Desk
SevereFDA (Drugs)·D-0552-2020·Announced 2019-12-11

QuVa Pharma Recalls Fentanyl and Ropivacaine Bags Due to Particulate Matter

QuVa Pharma is recalling specific lots of fentanyl and ropivacaine 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, which corresponds to a Severe severity score under the rubric, particularly given the risk of particulate matter in an injectable medication.

Plain-English summary

QuVa Pharma, Inc. is recalling specific lots of fentanyl 500 mcg/250 mL and ropivacaine HCl 0.2% 500 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 recalled the fentanyl active pharmaceutical ingredient (API) due to the potential for glass particles. The affected lots are distributed nationwide and include expiration dates ranging from November 2019 to January 2020.

Healthcare providers and patients should check their inventory and medication labels for the specific lot numbers listed in the recall notice. If you have this product, contact your healthcare provider or the manufacturer for instructions on how to proceed.

The recalled product

Product
fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1225-37
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 (14)

  • Lots: 10029346 Exp. 11/15/2019
  • 10029347 Exp. 11/15/2019
  • 10029982 Exp. 11/22/2019
  • 10030017 Exp. 11/24/2019
  • 10029982 11/22/2019
  • 10030401 Exp. 11/25/2019
  • 10031092 Exp. 12/6/2019
  • 10031092 12/6/2019
  • 10031349 Exp. 12/12/2019
  • 10032011 Exp. 12/27/2019
  • 10032012 Exp. 12/27/2019
  • 10032505 Exp. 1/5/2020
  • 10032447 Exp. 1/2/2020
  • 10032932 Exp. 1/13/2020

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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Same hazard · particulate matter

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