Fentanyl Bupivacaine Mix (QuVa Pharma) – 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) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37
Brand
QuVa Pharma, Inc.
Lot Codes / Batch Numbers
Lots: 10029289 Exp. 11/14/2019 10029841 Exp. 11/19/2019, 10029861 Exp. 11/19/2019, 10029863 Exp. 11/19/2019, 10030008 Exp. 11/24/2019, 10029946 Exp. 11/21/2019, 10030009 Exp. 11/24/2019, 10030010 Exp. 11/24/2019, 10030483 Exp. 11/27/2019, 10030482 Exp. 11/27/2019, 10030958 Exp. 12/3/2019, 10030908 Exp. 12/2/2019, 10030430 Exp. 11/26/2019, 10030989 Exp. 12/4/2019, 10030959 Exp. 12/3/2019, 10030907 Exp. 12/2/2019, 10030908 Exp. 12/2/2019, 10031283 Exp. 12/11/2019, 10031345 Exp. 12/12/2019, 10031346 Exp. 12/12/2019, 10031477 Exp. 12/16/2019, 10031433 Exp. 12/15/2019, 10031434 Exp. 12/15/2019, 10031478 Exp. 12/16/2019, 10031568 Exp. 12/18/2019, 10031615 Exp. 12/19/2019, 10031479 Exp. 12/18/2019, 10031568 Exp. 12/18/2019, 10031569 Exp. 12/18/2019, 10031570 Exp. 12/18/2019, 10031642 Exp. 12/20/2019, 10031591 Exp. 12/19/2019, 10031813 Exp. 12/23/2019, 10031814 Exp. 12/23/2019, 10032008 Exp. 12/27/2019, 10032009 Exp. 12/27/2019, 10031759 Exp. 12/26/2019, 10031946 Exp. 12/26/2019, 10031846 Exp. 12/24/2019, 10032250 Exp. 12/30/2019, 10031845 Exp. 12/24/2019, 10031846 Exp. 12/24/2019, 10032366 Exp. 1/1/2020, 10032391 Exp. 1/1/2020, 10032333 Exp. 12/31/2019, 10032445 Exp. 1/2/2020, 10031760 Exp. 1/7/2020, 10031975 Exp. 12/29/2019, 10031760 Exp. 1/7/2020, 10032533 Exp. 1/7/2020, 10031975 Exp. 12/29/2019, 10031976 Exp. 12/29/2019, 10031977 Exp. 12/29/2019, 10031760 Exp. 1/7/2020, 10032533 Exp. 1/7/2020, 10031976 Exp. 12/29/2019, 10031977 Exp. 12/29/2019, 10032664 Exp. 1/8/2020, 10032665 Exp. 1/8/2020, 10032533 Exp. 1/7/2020, 10032614 Exp. 1/7/2020, 10032615 Exp. 1/7/2020
Products Sold
Lots: 10029289 Exp. 11/14/2019 10029841 Exp. 11/19/2019, 10029861 Exp. 11/19/2019, 10029863 Exp. 11/19/2019, 10030008 Exp. 11/24/2019, 10029946 Exp. 11/21/2019, 10030009 Exp. 11/24/2019, 10030010 Exp. 11/24/2019, 10030483 Exp. 11/27/2019, 10030482 Exp. 11/27/2019, , 10030958 Exp. 12/3/2019, , 10030908 Exp. 12/2/2019, 10030430 Exp. 11/26/2019, 10030989 Exp. 12/4/2019, 10030959 Exp. 12/3/2019, 10030907 Exp. 12/2/2019, 10030908 Exp. 12/2/2019, 10031283 Exp. 12/11/2019, 10031345 Exp. 12/12/2019, 10031346 Exp. 12/12/2019, 10031477 Exp. 12/16/2019, 10031433 Exp. 12/15/2019, 10031434 Exp. 12/15/2019, 10031478 Exp. 12/16/2019, 10031568 Exp. 12/18/2019, 10031615 Exp. 12/19/2019, 10031479 Exp. 12/18/2019, 10031568 Exp. 12/18/2019, 10031569 Exp. 12/18/2019, 10031570 Exp. 12/18/2019, 10031642 Exp. 12/20/2019, 10031591 Exp. 12/19/2019, 10031813 Exp. 12/23/2019, 10031814 Exp. 12/23/2019, 10032008 Exp. 12/27/2019, 10032009 Exp. 12/27/2019, 10031759 Exp. 12/26/2019, 10031946 Exp. 12/26/2019, 10031846 Exp. 12/24/2019, 10032250 Exp. 12/30/2019, 10031845 Exp. 12/24/2019, 10031846 Exp. 12/24/2019, 10032366 Exp. 1/1/2020, 10032391 Exp. 1/1/2020, , 10032333 Exp. 12/31/2019, 10032445 Exp. 1/2/2020, 10031760 Exp. 1/7/2020, 10031975 Exp. 12/29/2019, 10031760 Exp. 1/7/2020, 10032533 Exp. 1/7/2020, 10031975 Exp. 12/29/2019, 10031976 Exp. 12/29/2019, 10031977 Exp. 12/29/2019, 10031760 Exp. 1/7/2020, 10032533 Exp. 1/7/2020, 10031976 Exp. 12/29/2019, 10031977 Exp. 12/29/2019, 10032664 Exp. 1/8/2020, 10032665 Exp. 1/8/2020, 10032533 Exp. 1/7/2020, , 10032614 Exp. 1/7/2020, 10032615 Exp. 1/7/2020
QuVa Pharma, Inc. is recalling fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodiu 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