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 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75
Brand
QuVa Pharma, Inc.
Lot Codes / Batch Numbers
Lots: 10029306 Exp. 11/14/2019, 10029881 Exp. 11/18/2019, 10029748 Exp. 11/17/2019, 10029881 Exp. 11/18/2019, 10029882 Exp. 11/18/2019, 10029854 Exp. 11/19/2019, 10029882 Exp. 11/18/2019, 10030947 Exp. 12/3/2019, 10030894 Exp. 12/2/2019, 10030442 Exp. 11/26/2019, 10031295 Exp. 12/11/2019, 10031319 Exp. 12/11/2019, 10031518 Exp. 12/17/2019, 10031553 Exp. 12/17/2019, 10031468 Exp. 12/16/2019, 10032703 Exp. 1/8/2020, 10032594 Exp. 1/6/2020, 10032543 Exp. 1/5/2020, 10031906 Exp. 12/25/2019, 10031882 Exp. 12/24/2019, 10031802 Exp. 12/23/2019, 10032594 Exp. 1/6/2020, 10032543 Exp. 1/5/2020, 10031906 Exp. 12/25/2019, 10031802 Exp. 12/23/2019, 10031775 Exp. 12/22/2019, 10031582 Exp. 12/18/2019, 10032673 Exp. 1/8/2020, 10032021 Exp. 12/27/2019, 10031582 Exp. 12/18/2019, 10032021 Exp. 12/27/2019, 10031960 Exp. 12/26/2019, 10031906 Exp. 12/25/2019, 10031582 Exp. 12/18/2019, 10032405 Exp. 1/1/2020, 10032021 Exp. 12/27/2019, 10031960 Exp. 12/26/2019, 10032380 Exp. 1/1/2020, 10032673 Exp. 1/8/2020
Products Sold
Lots: 10029306 Exp. 11/14/2019, 10029881 Exp. 11/18/2019, 10029748 Exp. 11/17/2019, 10029881 Exp. 11/18/2019, 10029882 Exp. 11/18/2019, 10029854 Exp. 11/19/2019, 10029882 Exp. 11/18/2019, 10030947 Exp. 12/3/2019, 10030894 Exp. 12/2/2019, 10030442 Exp. 11/26/2019, 10031295 Exp. 12/11/2019, 10031319 Exp. 12/11/2019, 10031518 Exp. 12/17/2019, 10031553 Exp. 12/17/2019, 10031468 Exp. 12/16/2019, 10032703 Exp. 1/8/2020, 10032594 Exp. 1/6/2020, 10032543 Exp. 1/5/2020, 10031906 Exp. 12/25/2019, 10031882 Exp. 12/24/2019, 10031802 Exp. 12/23/2019, 10032594 Exp. 1/6/2020, 10032543 Exp. 1/5/2020, 10031906 Exp. 12/25/2019, 10031802 Exp. 12/23/2019, 10031775 Exp. 12/22/2019, 10031582 Exp. 12/18/2019, 10032673 Exp. 1/8/2020, 10032021 Exp. 12/27/2019, 10031582 Exp. 12/18/2019, 10032021 Exp. 12/27/2019, 10031960 Exp. 12/26/2019, 10031906 Exp. 12/25/2019, 10031582 Exp. 12/18/2019, 10032405 Exp. 1/1/2020, 10032021 Exp. 12/27/2019, 10031960 Exp. 12/26/2019, 10032380 Exp. 1/1/2020, 10032673 Exp. 1/8/2020
QuVa Pharma, Inc. is recalling fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium 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