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) BUPivacaine HCl 0.1% 100 mg/100 mL (1 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 70092-1255-75
Brand
QuVa Pharma, Inc.
Lot Codes / Batch Numbers
Lots: 10029914 Exp. 11/20/2019, 10030342 Exp. 11/24/2019, 10030948 Exp. 12/3/2019, 10030895 Exp. 12/2/2019, 10030949 Exp. 12/3/2019, 10030895 Exp. 12/2/2019, 10031377 Exp. 12/6/2019, 10031141 Exp. 12/9/2019, 10031423 Exp. 12/15/2019, 10031627 Exp. 12/19/2019, 10031709 Exp. 12/22/2019, 10031907 Exp. 12/25/2019, 10032022 Exp. 12/27/2019, 10031858 Exp. 12/24/2019, 10032381 Exp. 1/1/2020, 10032296 Exp. 12/31/2019, 10032268 Exp. 12/30/2019, 10032467 Exp. 1/2/2020, 10032674 Exp. 1/8/2020, 10032569 Exp. 1/6/2020, 10032570 Exp. 1/6/2020, 10032516 Exp. 1/5/2020, 10032517 Exp. 1/5/2020, 10032674 Exp. 1/8/2020, 10032570 Exp. 1/6/2020, 10032675 Exp. 1/8/2020, 10033019 Exp. 1/15/2020
Products Sold
Lots: 10029914 Exp. 11/20/2019, 10030342 Exp. 11/24/2019, 10030948 Exp. 12/3/2019, 10030895 Exp. 12/2/2019, 10030949 Exp. 12/3/2019, 10030895 Exp. 12/2/2019, 10031377 Exp. 12/6/2019, 10031141 Exp. 12/9/2019, 10031423 Exp. 12/15/2019, 10031627 Exp. 12/19/2019, 10031709 Exp. 12/22/2019, 10031907 Exp. 12/25/2019, 10032022 Exp. 12/27/2019, 10031858 Exp. 12/24/2019, 10032381 Exp. 1/1/2020, 10032296 Exp. 12/31/2019, 10032268 Exp. 12/30/2019, 10032467 Exp. 1/2/2020, 10032674 Exp. 1/8/2020, 10032569 Exp. 1/6/2020, 10032570 Exp. 1/6/2020, 10032516 Exp. 1/5/2020, 10032517 Exp. 1/5/2020, 10032674 Exp. 1/8/2020, 10032570 Exp. 1/6/2020, 10032675 Exp. 1/8/2020, 10033019 Exp. 1/15/2020,
QuVa Pharma, Inc. is recalling fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 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