Fentanyl ROPivacaine Solution (QuVa) – Glass Particulate Risk (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
QuVa Pharma, Inc.
Lot Codes / Batch Numbers
Lots: 10029346 Exp. 11/15/2019, 10029347 Exp. 11/15/2019, 10029982 Exp. 11/22/2019, 10029347 Exp. 11/15/2019, 10029982 Exp. 11/22/2019, 10030017 Exp. 11/24/2019, 10029982 11/22/2019, 10030017 Exp. 11/24/2019, 10030401 Exp. 11/25/2019, 10030017 Exp. 11/24/2019, 10031092 Exp. 12/6/2019, 10030401 Exp. 11/25/2019, 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
Products Sold
Lots: 10029346 Exp. 11/15/2019, 10029347 Exp. 11/15/2019, 10029982 Exp. 11/22/2019, 10029347 Exp. 11/15/2019, 10029982 Exp. 11/22/2019, 10030017 Exp. 11/24/2019, 10029982 11/22/2019, 10030017 Exp. 11/24/2019, 10030401 Exp. 11/25/2019, 10030017 Exp. 11/24/2019, 10031092 Exp. 12/6/2019, 10030401 Exp. 11/25/2019, 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,
QuVa Pharma, Inc. is recalling fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chlor due to Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026