Fentanyl Citrate Bupivacaine (Pharmedium) – glass particulate 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
2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, flow stop free flow protection, Service Code 2K8972, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0972-48
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2K8210, Lot Number 160390175M, Exp. Date 5/9/2016, Service Code 2K8210, Lot Number 160400226M, Exp. Date 5/10/2016, Service Code 2K8210, Lot Number 160520170M, Exp. Date 5/22/2016, Service Code 2K8210, Lot Number 160590066M, Exp. Date 5/29/2016, Service Code 2K8210, Lot Number 160670046M, Exp. Date 6/5/2016, Service Code 2K8210, Lot Number 160680006M, Exp. Date 6/6/2016, Service Code 2K8210, Lot Number 160700027M, Exp. Date 6/8/2016, Service Code 2K8210, Lot Number 160730069M, Exp. Date 6/11/2016, Service Code 2K8210, Lot Number 160880217M, Exp. Date 6/27/2016, Service Code 2K8972, Lot Number 160450177M, Exp. Date 5/6/2016, Service Code 2K8972, Lot Number 160460196M, Exp. Date 5/7/2016, Service Code 2K8972, Lot Number 160600082M, Exp. Date 5/20/2016, Service Code 2K8972, Lot Number 160670061C, Exp. Date 5/28/2016, Service Code 2K8972, Lot Number 160740067C, Exp. Date 6/4/2016, Service Code 2K8972, Lot Number 160810085C, Exp. Date 6/11/2016, Service Code 2K8972, Lot Number 160950188M, Exp. Date 6/25/2016
Products Sold
Service Code 2K8210 , Lot Number 160390175M , Exp. Date 5/9/2016 ; Service Code 2K8210 , Lot Number 160400226M , Exp. Date 5/10/2016 ; Service Code 2K8210 , Lot Number 160520170M , Exp. Date 5/22/2016 ; Service Code 2K8210 , Lot Number 160590066M , Exp. Date 5/29/2016 ; Service Code 2K8210 , Lot Number 160670046M , Exp. Date 6/5/2016 ; Service Code 2K8210 , Lot Number 160680006M , Exp. Date 6/6/2016 ; Service Code 2K8210 , Lot Number 160700027M , Exp. Date 6/8/2016 ; Service Code 2K8210 , Lot Number 160730069M , Exp. Date 6/11/2016 ; Service Code 2K8210 , Lot Number 160880217M , Exp. Date 6/27/2016 ; Service Code 2K8972 , Lot Number 160450177M , Exp. Date 5/6/2016 ; Service Code 2K8972 , Lot Number 160460196M , Exp. Date 5/7/2016 ; Service Code 2K8972 , Lot Number 160600082M , Exp. Date 5/20/2016 ; Service Code 2K8972 , Lot Number 160670061C , Exp. Date 5/28/2016 ; Service Code 2K8972 , Lot Number 160740067C , Exp. Date 6/4/2016 ; Service Code 2K8972 , Lot Number 160810085C , Exp. Date 6/11/2016 ; Service Code 2K8972 , Lot Number 160950188M , Exp. Date 6/25/2016 ;
Pharmedium Services, LLC is recalling 2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 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