Fentanyl Bupivacaine Solution (Pharmedium) – Glass Contamination (2016)
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
2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2K9226, Lot Number 160450145M, Exp. Date 5/9/2016, Service Code 2K9226, Lot Number 160530166M, Exp. Date 5/17/2016, Service Code 2K9226, Lot Number 160560080M, Exp. Date 5/19/2016, Service Code 2K9226, Lot Number 160670164M, Exp. Date 5/31/2016, Service Code 2K9226, Lot Number 160730130M, Exp. Date 6/6/2016, Service Code 2K9226, Lot Number 160770032M, Exp. Date 6/10/2016, Service Code 2K9226, Lot Number 160810035M, Exp. Date 6/13/2016, Service Code 2K9226, Lot Number 160820135M, Exp. Date 6/15/2016, Service Code 2K9226, Lot Number 160870152M, Exp. Date 6/20/2016, Service Code 2K9226, Lot Number 160890036M, Exp. Date 6/22/2016, Service Code 2K9226, Lot Number 160950040M, Exp. Date 6/27/2016, Service Code 2K9294, Lot Number 160400210M, Exp. Date 5/10/2016, Service Code 2K9294, Lot Number 160700164M, Exp. Date 6/9/2016
Products Sold
Service Code 2K9226 , Lot Number 160450145M , Exp. Date 5/9/2016 ; Service Code 2K9226 , Lot Number 160530166M , Exp. Date 5/17/2016 ; Service Code 2K9226 , Lot Number 160560080M , Exp. Date 5/19/2016 ; Service Code 2K9226 , Lot Number 160670164M , Exp. Date 5/31/2016 ; Service Code 2K9226 , Lot Number 160730130M , Exp. Date 6/6/2016 ; Service Code 2K9226 , Lot Number 160770032M , Exp. Date 6/10/2016 ; Service Code 2K9226 , Lot Number 160810035M , Exp. Date 6/13/2016 ; Service Code 2K9226 , Lot Number 160820135M , Exp. Date 6/15/2016 ; Service Code 2K9226 , Lot Number 160870152M , Exp. Date 6/20/2016 ; Service Code 2K9226 , Lot Number 160890036M , Exp. Date 6/22/2016 ; Service Code 2K9226 , Lot Number 160950040M , Exp. Date 6/27/2016 ; Service Code 2K9294 , Lot Number 160400210M , Exp. Date 5/10/2016 ; Service Code 2K9294 , Lot Number 160700164M , Exp. Date 6/9/2016 ;
Pharmedium Services, LLC is recalling 2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 13 due to Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.. 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: API contaminated with glass particulate was used to produce sterile injectable drugs.
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