Fentanyl PCA Vial (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 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1180-79
Brand
QuVa Pharma, Inc.
Lot Codes / Batch Numbers
Lots: 10030060 Exp. 11/21/2019, 10030574 Exp. 11/28/2019, 10031353 Exp. 12/12/2019, 10031677 Exp. 12/20/2019, 10031622 Exp. 12/19/2019, 10031419 Exp. 12/15/2019, 10031769 Exp. 12/26/2019, 10031826 Exp. 12/23/2019, 10032287 Exp. 12/30/2019
Products Sold
Lots: 10030060 Exp. 11/21/2019, 10030574 Exp. 11/28/2019, 10031353 Exp. 12/12/2019, 10031677 Exp. 12/20/2019, 10031622 Exp. 12/19/2019, 10031419 Exp. 12/15/2019, 10031769 Exp. 12/26/2019, 10031826 Exp. 12/23/2019, 10032287 Exp. 12/30/2019
QuVa Pharma, Inc. is recalling fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park 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