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 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2H8138, Lot Number 160410192M, Exp. Date 5/11/2016, Service Code 2H8138, Lot Number 160600314M, Exp. Date 5/30/2016, Service Code 2H8138, Lot Number 160690002M, Exp. Date 6/7/2016, Service Code 2H8138, Lot Number 160690191M, Exp. Date 6/8/2016, Service Code 2H8138, Lot Number 160740233M, Exp. Date 6/13/2016, Service Code 2H8138, Lot Number 160760163M, Exp. Date 6/14/2016, Service Code 2H8138, Lot Number 160830226M, Exp. Date 6/22/2016, Service Code 2H8138, Lot Number 160890256M, Exp. Date 6/28/2016, Service Code 2H8138, Lot Number 160940138M, Exp. Date 7/3/2016, Service Code 2H8138, Lot Number 160960197M, Exp. Date 7/5/2016, Service Code 2H8138, Lot Number 161080219M, Exp. Date 7/17/2016, Service Code 2K8138, Lot Number 160450061M, Exp. Date 5/9/2016, Service Code 2K8138, Lot Number 160470232M, Exp. Date 5/11/2016, Service Code 2K8138, Lot Number 160480268M, Exp. Date 5/12/2016, Service Code 2K8138, Lot Number 160590083M, Exp. Date 5/23/2016, Service Code 2K8138, Lot Number 160630170M, Exp. Date 5/27/2016, Service Code 2K8138, Lot Number 160690170M, Exp. Date 6/2/2016, Service Code 2K8138, Lot Number 160700150M, Exp. Date 6/3/2016, Service Code 2K8138, Lot Number 160770283M, Exp. Date 6/10/2016, Service Code 2K8138, Lot Number 160840146M, Exp. Date 6/17/2016, Service Code 2K8138, Lot Number 160910269M, Exp. Date 6/24/2016, Service Code 2K8138, Lot Number 161080325M, Exp. Date 7/11/2016, Service Code 2K8807, Lot Number 160490044C, Exp. Date 5/10/2016, Service Code 2K8807, Lot Number 160630012C, Exp. Date 5/24/2016, Service Code 2K8807, Lot Number 160700033C, Exp. Date 5/31/2016, Service Code 2K8807, Lot Number 160970033C, Exp. Date 6/27/2016, Service Code 2K8872, Lot Number 160600059C, Exp. Date 5/21/2016, Service Code 2K8872, Lot Number 160630026C, Exp. Date 5/24/2016, Service Code 2K8872, Lot Number 160660158M, Exp. Date 5/27/2016, Service Code 2K8872, Lot Number 160740036M, Exp. Date 6/3/2016, Service Code 2K8872, Lot Number 160880252M, Exp. Date 6/18/2016, Service Code 2K8872, Lot Number 160940031C, Exp. Date 6/24/2016, Service Code 2K9138, Lot Number 160420038C, Exp. Date 5/12/2016, Service Code 2K9138, Lot Number 160460045C, Exp. Date 5/16/2016, Service Code 2K9138, Lot Number 160520033C, Exp. Date 5/22/2016, Service Code 2K9138, Lot Number 160530050C, Exp. Date 5/23/2016, Service Code 2K9138, Lot Number 160590029C, Exp. Date 5/29/2016, Service Code 2K9138, Lot Number 160600062C, Exp. Date 5/30/2016, Service Code 2K9138, Lot Number 160630033C, Exp. Date 6/2/2016, Service Code 2K9138, Lot Number 160670077C, Exp. Date 6/6/2016, Service Code 2K9138, Lot Number 160730033C, Exp. Date 6/12/2016, Service Code 2K9138, Lot Number 160770056C, Exp. Date 6/16/2016, Service Code 2K9138, Lot Number 160880076C, Exp. Date 6/27/2016, Service Code 2K9138, Lot Number 160910024C, Exp. Date 6/30/2016, Service Code 2K9138, Lot Number 160950084C, Exp. Date 7/4/2016, Service Code 2K9138, Lot Number 160960054C, Exp. Date 7/5/2016, Service Code 2T6257, Lot Number 160450201M, Exp. Date 5/15/2016, Service Code 2T6257, Lot Number 160620194M, Exp. Date 6/1/2016, Service Code 2T6257, Lot Number 160810203M, Exp. Date 6/20/2016, Service Code 2T6257, Lot Number 160820230M, Exp. Date 6/21/2016, Service Code 2T6257, Lot Number 160870153M, Exp. Date 6/26/2016, Service Code 2T6257, Lot Number 160880278M, Exp. Date 6/27/2016, Service Code 2T6257, Lot Number 160950233M, Exp. Date 7/4/2016, Service Code 2T8141, Lot Number 160450016C, Exp. Date 5/6/2016, Service Code 2T8141, Lot Number 160520016C, Exp. Date 5/13/2016, Service Code 2T8141, Lot Number 160530019C, Exp. Date 5/14/2016, Service Code 2T8141, Lot Number 160590009C, Exp. Date 5/20/2016, Service Code 2T8141, Lot Number 160670022C, Exp. Date 5/28/2016, Service Code 2T8141, Lot Number 160730011C, Exp. Date 6/3/2016, Service Code 2T8141, Lot Number 160740029C, Exp. Date 6/3/2016, Service Code 2T8141, Lot Number 160800022C, Exp. Date 6/10/2016, Service Code 2T8141, Lot Number 160870008C, Exp. Date 6/17/2016
Products Sold
Service Code 2H8138 , Lot Number 160410192M , Exp. Date 5/11/2016 ; Service Code 2H8138 , Lot Number 160600314M , Exp. Date 5/30/2016 ; Service Code 2H8138 , Lot Number 160690002M , Exp. Date 6/7/2016 ; Service Code 2H8138 , Lot Number 160690191M , Exp. Date 6/8/2016 ; Service Code 2H8138 , Lot Number 160740233M , Exp. Date 6/13/2016 ; Service Code 2H8138 , Lot Number 160760163M , Exp. Date 6/14/2016 ; Service Code 2H8138 , Lot Number 160830226M , Exp. Date 6/22/2016 ; Service Code 2H8138 , Lot Number 160890256M , Exp. Date 6/28/2016 ; Service Code 2H8138 , Lot Number 160940138M , Exp. Date 7/3/2016 ; Service Code 2H8138 , Lot Number 160960197M , Exp. Date 7/5/2016 ; Service Code 2H8138 , Lot Number 161080219M , Exp. Date 7/17/2016 ; Service Code 2K8138 , Lot Number 160450061M , Exp. Date 5/9/2016 ; Service Code 2K8138 , Lot Number 160470232M , Exp. Date 5/11/2016 ; Service Code 2K8138 , Lot Number 160480268M , Exp. Date 5/12/2016 ; Service Code 2K8138 , Lot Number 160590083M , Exp. Date 5/23/2016 ; Service Code 2K8138 , Lot Number 160630170M , Exp. Date 5/27/2016 ; Service Code 2K8138 , Lot Number 160690170M , Exp. Date 6/2/2016 ; Service Code 2K8138 , Lot Number 160700150M , Exp. Date 6/3/2016 ; Service Code 2K8138 , Lot Number 160770283M , Exp. Date 6/10/2016 ; Service Code 2K8138 , Lot Number 160840146M , Exp. Date 6/17/2016 ; Service Code 2K8138 , Lot Number 160910269M , Exp. Date 6/24/2016 ; Service Code 2K8138 , Lot Number 161080325M , Exp. Date 7/11/2016 ; Service Code 2K8807 , Lot Number 160490044C , Exp. Date 5/10/2016 ; Service Code 2K8807 , Lot Number 160630012C , Exp. Date 5/24/2016 ; Service Code 2K8807 , Lot Number 160700033C , Exp. Date 5/31/2016 ; Service Code 2K8807 , Lot Number 160970033C , Exp. Date 6/27/2016 ; Service Code 2K8872 , Lot Number 160600059C , Exp. Date 5/21/2016 ; Service Code 2K8872 , Lot Number 160630026C , Exp. Date 5/24/2016 ; Service Code 2K8872 , Lot Number 160660158M , Exp. Date 5/27/2016 ; Service Code 2K8872 , Lot Number 160740036M , Exp. Date 6/3/2016 ; Service Code 2K8872 , Lot Number 160880252M , Exp. Date 6/18/2016 ; Service Code 2K8872 , Lot Number 160940031C , Exp. Date 6/24/2016 ; Service Code 2K9138 , Lot Number 160420038C , Exp. Date 5/12/2016 ; Service Code 2K9138 , Lot Number 160460045C , Exp. Date 5/16/2016 ; Service Code 2K9138 , Lot Number 160520033C , Exp. Date 5/22/2016 ; Service Code 2K9138 , Lot Number 160530050C , Exp. Date 5/23/2016 ; Service Code 2K9138 , Lot Number 160590029C , Exp. Date 5/29/2016 ; Service Code 2K9138 , Lot Number 160600062C , Exp. Date 5/30/2016 ; Service Code 2K9138 , Lot Number 160630033C , Exp. Date 6/2/2016 ; Service Code 2K9138 , Lot Number 160670077C , Exp. Date 6/6/2016 ; Service Code 2K9138 , Lot Number 160730033C , Exp. Date 6/12/2016 ; Service Code 2K9138 , Lot Number 160770056C , Exp. Date 6/16/2016 ; Service Code 2K9138 , Lot Number 160880076C , Exp. Date 6/27/2016 ; Service Code 2K9138 , Lot Number 160910024C , Exp. Date 6/30/2016 ; Service Code 2K9138 , Lot Number 160950084C , Exp. Date 7/4/2016 ; Service Code 2K9138 , Lot Number 160960054C , Exp. Date 7/5/2016 ; Service Code 2T6257 , Lot Number 160450201M , Exp. Date 5/15/2016 ; Service Code 2T6257 , Lot Number 160620194M , Exp. Date 6/1/2016 ; Service Code 2T6257 , Lot Number 160810203M , Exp. Date 6/20/2016 ; Service Code 2T6257 , Lot Number 160820230M , Exp. Date 6/21/2016 ; Service Code 2T6257 , Lot Number 160870153M , Exp. Date 6/26/2016 ; Service Code 2T6257 , Lot Number 160880278M , Exp. Date 6/27/2016 ; Service Code 2T6257 , Lot Number 160950233M , Exp. Date 7/4/2016 ; Service Code 2T8141 , Lot Number 160450016C , Exp. Date 5/6/2016 ; Service Code 2T8141 , Lot Number 160520016C , Exp. Date 5/13/2016 ; Service Code 2T8141 , Lot Number 160530019C , Exp. Date 5/14/2016 ; Service Code 2T8141 , Lot Number 160590009C , Exp. Date 5/20/2016 ; Service Code 2T8141 , Lot Number 160670022C , Exp. Date 5/28/2016 ; Service Code 2T8141 , Lot Number 160730011C , Exp. Date 6/3/2016 ; Service Code 2T8141 , Lot Number 160740029C , Exp. Date 6/3/2016 ; Service Code 2T8141 , Lot Number 160800022C , Exp. Date 6/10/2016 ; Service Code 2T8141 , Lot Number 160870008C , Exp. Date 6/17/2016 ;
Pharmedium Services, LLC is recalling 5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 m 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