Fentanyl Bupivacaine Injection (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) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37
Brand
QuVa Pharma, Inc.
Lot Codes / Batch Numbers
Lots: 10029297 Exp. 11/14/2019 10029199 Exp. 11/17/2019, 10029737 Exp. 11/17/2019, 10029763 Exp. 11/17/2019, 10029785 Exp. 11/18/2019, 10029789 Exp. 11/18/2019, 10029790 Exp. 11/18/2019, 10029894 Exp. 11/20/2019, 10029950 Exp. 11/21/2019, 10030006 Exp. 11/24/2019, 10030007 Exp. 11/27/2019, 10030336 Exp. 11/27/2019, 10030941 Exp. 12/3/2019, 10030886 Exp. 12/2/2019, 10030453 Exp. 11/26/2019, 10030887 Exp. 12/4/2019, 10030990 Exp. 12/4/2019, 10030991 Exp. 12/4/2019, 10030942 Exp. 12/3/2019, 10030886 Exp. 12/2/2019, 10030909 Exp. 12/2/2019, 10030431 Exp. 11/26/2019, 10030432 Exp. 11/26/2019, 10030454 Exp. 11/26/2019, 10031056 Exp. 12/5/2019, 10031057 Exp. 12/5/2019, 10030990 Exp. 12/4/2019, 10030886 Exp. 12/2/2019, 10030454 Exp. 11/26/2019, 10031056 Exp. 12/5/2019, 10031058 Exp. 12/5/2019, 10031087 Exp. 12/6/2019, 10031153 Exp. 12/8/2019, 10031087 Exp. 12/6/2019, 10031088 Exp. 12/6/2019, 10031376 Exp. 12/6/2019, 10031178 Exp. 12/9/2019, 10031179 Exp. 12/9/2019, 10031152 Exp. 12/8/2019, 10031153 Exp. 12/8/2019, 10031376 Exp. 12/6/2019, 10031236 Exp. 12/10/2019, 10031179 Exp. 12/9/2019, 10031152 Exp. 12/8/2019, 10031236 Exp. 12/10/2019, 10031237 Exp. 12/10/2019, 10031732 Exp. 12/22/2019, 10031616 Exp. 12/19/2019, 10031617 Exp. 12/22/2019, 10031731 Exp. 12/22/2019, 10031732 Exp. 12/22/2019, 10031616 Exp. 12/19/2019, 10031617 Exp. 12/22/2019, 10031950 Exp. 12/26/2019, 10031979 Exp. 12/29/2019, 10031980 Exp. 12/30/2019, 10032308 Exp. 12/31/2019, 10032309 Exp. 12/31/2019, 10032415 Exp. 1/2/2020, 10032416 Exp. 1/2/2020, 10032804 Exp. 1/5/2020, 10032805 Exp. 1/5/2020, 10032582 Exp. 1/6/2020, 10032808 Exp. 1/6/2020, 10032809 Exp. 1/6/2020, 10032810 Exp. 1/6/2020, 10032559 Exp. 1/6/2020, 10032582 Exp. 1/6/2020, 10032809 Exp. 1/6/2020, 10032810 Exp. 1/6/2020, 10032811 Exp. 1/6/2020, 10032805 Exp. 1/5/2020, 10032805 Exp. 1/5/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10033008 Exp. 1/15/2020, 10033008 Exp. 1/15/2020, 10032038 Exp. 1/19/2020, 10032038 Exp. 1/19/2020, 10032039 Exp. 1/19/2020, 10033008 Exp. 1/15/2020, 10032039 Exp. 1/19/2020
Products Sold
Lots: 10029297 Exp. 11/14/2019 10029199 Exp. 11/17/2019, 10029737 Exp. 11/17/2019, 10029763 Exp. 11/17/2019, 10029785 Exp. 11/18/2019, 10029789 Exp. 11/18/2019, , 10029790 Exp. 11/18/2019, 10029894 Exp. 11/20/2019, 10029950 Exp. 11/21/2019, 10030006 Exp. 11/24/2019, , 10030007 Exp. 11/27/2019, 10030336 Exp. 11/27/2019, , 10030941 Exp. 12/3/2019, 10030886 Exp. 12/2/2019, 10030453 Exp. 11/26/2019, 10030887 Exp. 12/4/2019, 10030990 Exp. 12/4/2019, 10030991 Exp. 12/4/2019,, 10030942 Exp. 12/3/2019, 10030886 Exp. 12/2/2019, 10030909 Exp. 12/2/2019, 10030431 Exp. 11/26/2019, 10030432 Exp. 11/26/2019, 10030454 Exp. 11/26/2019, 10031056 Exp. 12/5/2019, 10031057 Exp. 12/5/2019, 10030990 Exp. 12/4/2019, 10030886 Exp. 12/2/2019,, 10030454 Exp. 11/26/2019, 10031056 Exp. 12/5/2019, 10031058 Exp. 12/5/2019, 10031087 Exp. 12/6/2019, 10031153 Exp. 12/8/2019, 10031087 Exp. 12/6/2019, 10031088 Exp. 12/6/2019, 10031376 Exp. 12/6/2019, 10031178 Exp. 12/9/2019, 10031179 Exp. 12/9/2019, 10031152 Exp. 12/8/2019, 10031153 Exp. 12/8/2019, 10031376 Exp. 12/6/2019, 10031236 Exp. 12/10/2019, 10031179 Exp. 12/9/2019, 10031152 Exp. 12/8/2019, 10031236 Exp. 12/10/2019, 10031237 Exp. 12/10/2019, 10031732 Exp. 12/22/2019, 10031616 Exp. 12/19/2019, 10031617 Exp. 12/22/2019, 10031731 Exp. 12/22/2019, 10031732 Exp. 12/22/2019, 10031616 Exp. 12/19/2019, 10031617 Exp. 12/22/2019, 10031950 Exp. 12/26/2019, 10031979 Exp. 12/29/2019, 10031980 Exp. 12/30/2019, 10032308 Exp. 12/31/2019, 10032309 Exp. 12/31/2019, 10032415 Exp. 1/2/2020, 10032416 Exp. 1/2/2020, 10032804 Exp. 1/5/2020, 10032805 Exp. 1/5/2020, 10032582 Exp. 1/6/2020, 10032808 Exp. 1/6/2020, 10032809 Exp. 1/6/2020, 10032810 Exp. 1/6/2020, 10032559 Exp. 1/6/2020, 10032582 Exp. 1/6/2020, 10032809 Exp. 1/6/2020, 10032810 Exp. 1/6/2020, 10032811 Exp. 1/6/2020, 10032805 Exp. 1/5/2020, 10032805 Exp. 1/5/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10033008 Exp. 1/15/2020, 10033008 Exp. 1/15/2020, 10032038 Exp. 1/19/2020, 10032038 Exp. 1/19/2020, 10032039 Exp. 1/19/2020, 10033008 Exp. 1/15/2020, 10032039 Exp. 1/19/2020
QuVa Pharma, Inc. is recalling fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 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