Fentanyl Citrate with Bupivacaine (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
5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD Syringe, Service Code 2T6140 (NDC 61553-140-20) , 60 mL in 60 mL BD Syringe, Service Code 2T6222 (NDC 61553-222-31), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2H8139, Lot Number 160420171M, Exp. Date 5/12/2016, Service Code 2H8139, Lot Number 160460111M, Exp. Date 5/16/2016, Service Code 2H8139, Lot Number 160490001M, Exp. Date 5/18/2016, Service Code 2H8139, Lot Number 160530289M, Exp. Date 5/23/2016, Service Code 2H8139, Lot Number 160560215M, Exp. Date 5/26/2016, Service Code 2H8139, Lot Number 160590055M, Exp. Date 5/29/2016, Service Code 2H8139, Lot Number 160600232M, Exp. Date 5/30/2016, Service Code 2H8139, Lot Number 160610189M, Exp. Date 5/31/2016, Service Code 2H8139, Lot Number 160670159M, Exp. Date 6/6/2016, Service Code 2H8139, Lot Number 160740151M, Exp. Date 6/13/2016, Service Code 2H8139, Lot Number 160770172M, Exp. Date 6/16/2016, Service Code 2H8139, Lot Number 160800069M, Exp. Date 6/18/2016, Service Code 2H8139, Lot Number 160810208M, Exp. Date 6/20/2016, Service Code 2H8139, Lot Number 160900168M, Exp. Date 6/29/2016, Service Code 2H8139, Lot Number 160960158M, Exp. Date 7/5/2016, Service Code 2H8139, Lot Number 161080229M, Exp. Date 7/17/2016, Service Code 2H8140, Lot Number 160450212M, Exp. Date 5/11/2016, Service Code 2H8140, Lot Number 160550237M, Exp. Date 5/21/2016, Service Code 2H8140, Lot Number 160660222M, Exp. Date 6/1/2016, Service Code 2H8140, Lot Number 160670248M, Exp. Date 6/2/2016, Service Code 2H8140, Lot Number 160700215M, Exp. Date 6/5/2016, Service Code 2H8140, Lot Number 160870227M, Exp. Date 6/22/2016, Service Code 2H8140, Lot Number 160880150M, Exp. Date 6/23/2016, Service Code 2H8140, Lot Number 160940208M, Exp. Date 6/29/2016, Service Code 2H8140, Lot Number 161080214M, Exp. Date 7/13/2016, Service Code 2K8139, Lot Number 160450047M, Exp. Date 5/9/2016, Service Code 2K8139, Lot Number 160590188M, Exp. Date 5/23/2016, Service Code 2K8139, Lot Number 160610248M, Exp. Date 5/25/2016, Service Code 2K8139, Lot Number 160730263M, Exp. Date 6/6/2016, Service Code 2K8139, Lot Number 160770133M, Exp. Date 6/10/2016, Service Code 2K8139, Lot Number 160820143M, Exp. Date 6/15/2016, Service Code 2K8139, Lot Number 160880151M, Exp. Date 6/21/2016, Service Code 2K8139, Lot Number 160910235M, Exp. Date 6/24/2016, Service Code 2K8247, Lot Number 160400202M, Exp. Date 5/10/2016, Service Code 2K8247, Lot Number 160460151M, Exp. Date 5/16/2016, Service Code 2K8247, Lot Number 160470188M, Exp. Date 5/17/2016, Service Code 2K8247, Lot Number 160590141M, Exp. Date 5/29/2016, Service Code 2K8247, Lot Number 160620192M, Exp. Date 6/1/2016, Service Code 2K8247, Lot Number 160700158M, Exp. Date 6/9/2016, Service Code 2K8247, Lot Number 160820178M, Exp. Date 6/21/2016, Service Code 2K8247, Lot Number 160840216M, Exp. Date 6/23/2016, Service Code 2K8247, Lot Number 160910142M, Exp. Date 6/30/2016, Service Code 2K8247, Lot Number 160940212M, Exp. Date 7/3/2016, Service Code 2K8247, Lot Number 161080223M, Exp. Date 7/17/2016, Service Code 2K8813, Lot Number 160450175M, Exp. Date 5/6/2016, Service Code 2K8813, Lot Number 160460213M, Exp. Date 5/7/2016, Service Code 2K8813, Lot Number 160480240M, Exp. Date 5/9/2016, Service Code 2K8813, Lot Number 160520185M, Exp. Date 5/13/2016, Service Code 2K8813, Lot Number 160560083M, Exp. Date 5/16/2016, Service Code 2K8813, Lot Number 160630156M, Exp. Date 5/24/2016, Service Code 2K8813, Lot Number 160700166M, Exp. Date 5/31/2016, Service Code 2K8813, Lot Number 160770183M, Exp. Date 6/7/2016, Service Code 2K8813, Lot Number 160830180M, Exp. Date 6/13/2016, Service Code 2K8813, Lot Number 160910180M, Exp. Date 6/21/2016, Service Code 2K8875, Lot Number 160660143M, Exp. Date 5/27/2016, Service Code 2K8875, Lot Number 160770127M, Exp. Date 6/7/2016, Service Code 2K8875, Lot Number 160940123M, Exp. Date 6/24/2016, Service Code 2K8876, Lot Number 160490225M, Exp. Date 5/10/2016, Service Code 2K8876, Lot Number 160540244M, Exp. Date 5/15/2016, Service Code 2K8876, Lot Number 160540245M, Exp. Date 5/15/2016, Service Code 2K8876, Lot Number 160630129M, Exp. Date 5/24/2016, Service Code 2K8876, Lot Number 160700161M, Exp. Date 5/31/2016, Service Code 2K8876, Lot Number 160770137M, Exp. Date 6/7/2016, Service Code 2K8876, Lot Number 160810190M, Exp. Date 6/11/2016, Service Code 2K8876, Lot Number 160830187M, Exp. Date 6/13/2016, Service Code 2K8876, Lot Number 160830188M, Exp. Date 6/13/2016, Service Code 2K8876, Lot Number 160830189M, Exp. Date 6/13/2016, Service Code 2K8876, Lot Number 160910229M, Exp. Date 6/21/2016, Service Code 2K8876, Lot Number 161080079M, Exp. Date 7/7/2016, Service Code 2T6140, Lot Number 160380106M, Exp. Date 5/7/2016, Service Code 2T6140, Lot Number 160460193M, Exp. Date 5/16/2016, Service Code 2T6140, Lot Number 160520182M, Exp. Date 5/22/2016, Service Code 2T6140, Lot Number 160540193M, Exp. Date 5/23/2016, Service Code 2T6140, Lot Number 160560094M, Exp. Date 5/25/2016, Service Code 2T6140, Lot Number 160600050M, Exp. Date 5/29/2016, Service Code 2T6140, Lot Number 160660153M, Exp. Date 6/5/2016, Service Code 2T6140, Lot Number 160950214M, Exp. Date 7/4/2016, Service Code 2T6222, Lot Number 160420160M, Exp. Date 5/11/2016, Service Code 2T8875, Lot Number 160960145M, Exp. Date 5/6/2016, Service Code 2T8876, Lot Number 160960131M, Exp. Date 5/6/2016, Service Code 4J8139, Lot Number 160460122M, Exp. Date 5/10/2016, Service Code 4J8139, Lot Number 160680045M, Exp. Date 5/31/2016, Service Code 4J8139, Lot Number 160810171M, Exp. Date 6/14/2016, Service Code 4J8139, Lot Number 160950057M, Exp. Date 6/27/2016
Products Sold
Service Code 2H8139 , Lot Number 160420171M , Exp. Date 5/12/2016 ; Service Code 2H8139 , Lot Number 160460111M , Exp. Date 5/16/2016 ; Service Code 2H8139 , Lot Number 160490001M , Exp. Date 5/18/2016 ; Service Code 2H8139 , Lot Number 160530289M , Exp. Date 5/23/2016 ; Service Code 2H8139 , Lot Number 160560215M , Exp. Date 5/26/2016 ; Service Code 2H8139 , Lot Number 160590055M , Exp. Date 5/29/2016 ; Service Code 2H8139 , Lot Number 160600232M , Exp. Date 5/30/2016 ; Service Code 2H8139 , Lot Number 160610189M , Exp. Date 5/31/2016 ; Service Code 2H8139 , Lot Number 160670159M , Exp. Date 6/6/2016 ; Service Code 2H8139 , Lot Number 160740151M , Exp. Date 6/13/2016 ; Service Code 2H8139 , Lot Number 160770172M , Exp. Date 6/16/2016 ; Service Code 2H8139 , Lot Number 160800069M , Exp. Date 6/18/2016 ; Service Code 2H8139 , Lot Number 160810208M , Exp. Date 6/20/2016 ; Service Code 2H8139 , Lot Number 160900168M , Exp. Date 6/29/2016 ; Service Code 2H8139 , Lot Number 160960158M , Exp. Date 7/5/2016 ; Service Code 2H8139 , Lot Number 161080229M , Exp. Date 7/17/2016 ; Service Code 2H8140 , Lot Number 160450212M , Exp. Date 5/11/2016 ; Service Code 2H8140 , Lot Number 160550237M , Exp. Date 5/21/2016 ; Service Code 2H8140 , Lot Number 160660222M , Exp. Date 6/1/2016 ; Service Code 2H8140 , Lot Number 160670248M , Exp. Date 6/2/2016 ; Service Code 2H8140 , Lot Number 160700215M , Exp. Date 6/5/2016 ; Service Code 2H8140 , Lot Number 160870227M , Exp. Date 6/22/2016 ; Service Code 2H8140 , Lot Number 160880150M , Exp. Date 6/23/2016 ; Service Code 2H8140 , Lot Number 160940208M , Exp. Date 6/29/2016 ; Service Code 2H8140 , Lot Number 161080214M , Exp. Date 7/13/2016 ; Service Code 2K8139 , Lot Number 160450047M , Exp. Date 5/9/2016 ; Service Code 2K8139 , Lot Number 160590188M , Exp. Date 5/23/2016 ; Service Code 2K8139 , Lot Number 160610248M , Exp. Date 5/25/2016 ; Service Code 2K8139 , Lot Number 160730263M , Exp. Date 6/6/2016 ; Service Code 2K8139 , Lot Number 160770133M , Exp. Date 6/10/2016 ; Service Code 2K8139 , Lot Number 160820143M , Exp. Date 6/15/2016 ; Service Code 2K8139 , Lot Number 160880151M , Exp. Date 6/21/2016 ; Service Code 2K8139 , Lot Number 160910235M , Exp. Date 6/24/2016 ; Service Code 2K8247 , Lot Number 160400202M , Exp. Date 5/10/2016 ; Service Code 2K8247 , Lot Number 160460151M , Exp. Date 5/16/2016 ; Service Code 2K8247 , Lot Number 160470188M , Exp. Date 5/17/2016 ; Service Code 2K8247 , Lot Number 160590141M , Exp. Date 5/29/2016 ; Service Code 2K8247 , Lot Number 160620192M , Exp. Date 6/1/2016 ; Service Code 2K8247 , Lot Number 160700158M , Exp. Date 6/9/2016 ; Service Code 2K8247 , Lot Number 160820178M , Exp. Date 6/21/2016 ; Service Code 2K8247 , Lot Number 160840216M , Exp. Date 6/23/2016 ; Service Code 2K8247 , Lot Number 160910142M , Exp. Date 6/30/2016 ; Service Code 2K8247 , Lot Number 160940212M , Exp. Date 7/3/2016 ; Service Code 2K8247 , Lot Number 161080223M , Exp. Date 7/17/2016 ; Service Code 2K8813 , Lot Number 160450175M , Exp. Date 5/6/2016 ; Service Code 2K8813 , Lot Number 160460213M , Exp. Date 5/7/2016 ; Service Code 2K8813 , Lot Number 160480240M , Exp. Date 5/9/2016 ; Service Code 2K8813 , Lot Number 160520185M , Exp. Date 5/13/2016 ; Service Code 2K8813 , Lot Number 160560083M , Exp. Date 5/16/2016 ; Service Code 2K8813 , Lot Number 160630156M , Exp. Date 5/24/2016 ; Service Code 2K8813 , Lot Number 160700166M , Exp. Date 5/31/2016 ; Service Code 2K8813 , Lot Number 160770183M , Exp. Date 6/7/2016 ; Service Code 2K8813 , Lot Number 160830180M , Exp. Date 6/13/2016 ; Service Code 2K8813 , Lot Number 160910180M , Exp. Date 6/21/2016 ; Service Code 2K8875 , Lot Number 160660143M , Exp. Date 5/27/2016 ; Service Code 2K8875 , Lot Number 160770127M , Exp. Date 6/7/2016 ; Service Code 2K8875 , Lot Number 160940123M , Exp. Date 6/24/2016 ; Service Code 2K8876 , Lot Number 160490225M , Exp. Date 5/10/2016 ; Service Code 2K8876 , Lot Number 160540244M , Exp. Date 5/15/2016 ; Service Code 2K8876 , Lot Number 160540245M , Exp. Date 5/15/2016 ; Service Code 2K8876 , Lot Number 160630129M , Exp. Date 5/24/2016 ; Service Code 2K8876 , Lot Number 160700161M , Exp. Date 5/31/2016 ; Service Code 2K8876 , Lot Number 160770137M , Exp. Date 6/7/2016 ; Service Code 2K8876 , Lot Number 160810190M , Exp. Date 6/11/2016 ; Service Code 2K8876 , Lot Number 160830187M , Exp. Date 6/13/2016 ; Service Code 2K8876 , Lot Number 160830188M , Exp. Date 6/13/2016 ; Service Code 2K8876 , Lot Number 160830189M , Exp. Date 6/13/2016 ; Service Code 2K8876 , Lot Number 160910229M , Exp. Date 6/21/2016 ; Service Code 2K8876 , Lot Number 161080079M , Exp. Date 7/7/2016 ; Service Code 2T6140 , Lot Number 160380106M , Exp. Date 5/7/2016 ; Service Code 2T6140 , Lot Number 160460193M , Exp. Date 5/16/2016 ; Service Code 2T6140 , Lot Number 160520182M , Exp. Date 5/22/2016 ; Service Code 2T6140 , Lot Number 160540193M , Exp. Date 5/23/2016 ; Service Code 2T6140 , Lot Number 160560094M , Exp. Date 5/25/2016 ; Service Code 2T6140 , Lot Number 160600050M , Exp. Date 5/29/2016 ; Service Code 2T6140 , Lot Number 160660153M , Exp. Date 6/5/2016 ; Service Code 2T6140 , Lot Number 160950214M , Exp. Date 7/4/2016 ; Service Code 2T6222 , Lot Number 160420160M , Exp. Date 5/11/2016 ; Service Code 2T8875 , Lot Number 160960145M , Exp. Date 5/6/2016 ; Service Code 2T8876 , Lot Number 160960131M , Exp. Date 5/6/2016 ; Service Code 4J8139 , Lot Number 160460122M , Exp. Date 5/10/2016 ; Service Code 4J8139 , Lot Number 160680045M , Exp. Date 5/31/2016 ; Service Code 4J8139 , Lot Number 160810171M , Exp. Date 6/14/2016 ; Service Code 4J8139 , Lot Number 160950057M , Exp. Date 6/27/2016 ;
Pharmedium Services, LLC is recalling 5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 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