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 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2H8255, Lot Number 160550161M, Exp. Date 5/11/2016, Service Code 2H8255, Lot Number 160620170M, Exp. Date 5/18/2016, Service Code 2H8255, Lot Number 160760132M, Exp. Date 6/1/2016, Service Code 2H8255, Lot Number 160830148M, Exp. Date 6/8/2016, Service Code 2H8255, Lot Number 160900158M, Exp. Date 6/15/2016, Service Code 2H8255, Lot Number 160970139M, Exp. Date 6/22/2016, Service Code 2K8255, Lot Number 160490046C, Exp. Date 5/13/2016, Service Code 2K8255, Lot Number 160620032C, Exp. Date 5/26/2016, Service Code 2K8255, Lot Number 160770046C, Exp. Date 6/10/2016, Service Code 2K8464, Lot Number 160420154M, Exp. Date 5/6/2016, Service Code 2K8464, Lot Number 160530249M, Exp. Date 5/17/2016, Service Code 2K8464, Lot Number 160540207M, Exp. Date 5/18/2016, Service Code 2K8464, Lot Number 160660045M, Exp. Date 5/29/2016, Service Code 2K8464, Lot Number 160730092M, Exp. Date 6/6/2016, Service Code 2K8464, Lot Number 160840137M, Exp. Date 6/17/2016, Service Code 2K8464, Lot Number 160910145M, Exp. Date 6/24/2016, Service Code 2T8255, Lot Number 160480271M, Exp. Date 5/9/2016, Service Code 2T8255, Lot Number 160530302M, Exp. Date 5/14/2016, Service Code 2T8255, Lot Number 160600047C, Exp. Date 5/21/2016, Service Code 2T8255, Lot Number 160610032C, Exp. Date 5/22/2016, Service Code 2T8255, Lot Number 160700030C, Exp. Date 5/30/2016, Service Code 2T8255, Lot Number 160700031C, Exp. Date 5/31/2016, Service Code 2T8255, Lot Number 160740060C, Exp. Date 6/4/2016, Service Code 2T8255, Lot Number 160770034C, Exp. Date 6/7/2016, Service Code 2T8255, Lot Number 160830059C, Exp. Date 6/13/2016, Service Code 2T8255, Lot Number 160880040C, Exp. Date 6/18/2016, Service Code 2T8255, Lot Number 160880041C, Exp. Date 6/18/2016, Service Code 2T8255, Lot Number 160940029C, Exp. Date 6/24/2016, Service Code 2T8255, Lot Number 160950051C, Exp. Date 6/25/2016
Products Sold
Service Code 2H8255 , Lot Number 160550161M , Exp. Date 5/11/2016 ; Service Code 2H8255 , Lot Number 160620170M , Exp. Date 5/18/2016 ; Service Code 2H8255 , Lot Number 160760132M , Exp. Date 6/1/2016 ; Service Code 2H8255 , Lot Number 160830148M , Exp. Date 6/8/2016 ; Service Code 2H8255 , Lot Number 160900158M , Exp. Date 6/15/2016 ; Service Code 2H8255 , Lot Number 160970139M , Exp. Date 6/22/2016 ; Service Code 2K8255 , Lot Number 160490046C , Exp. Date 5/13/2016 ; Service Code 2K8255 , Lot Number 160620032C , Exp. Date 5/26/2016 ; Service Code 2K8255 , Lot Number 160770046C , Exp. Date 6/10/2016 ; Service Code 2K8464 , Lot Number 160420154M , Exp. Date 5/6/2016 ; Service Code 2K8464 , Lot Number 160530249M , Exp. Date 5/17/2016 ; Service Code 2K8464 , Lot Number 160540207M , Exp. Date 5/18/2016 ; Service Code 2K8464 , Lot Number 160660045M , Exp. Date 5/29/2016 ; Service Code 2K8464 , Lot Number 160730092M , Exp. Date 6/6/2016 ; Service Code 2K8464 , Lot Number 160840137M , Exp. Date 6/17/2016 ; Service Code 2K8464 , Lot Number 160910145M , Exp. Date 6/24/2016 ; Service Code 2T8255 , Lot Number 160480271M , Exp. Date 5/9/2016 ; Service Code 2T8255 , Lot Number 160530302M , Exp. Date 5/14/2016 ; Service Code 2T8255 , Lot Number 160600047C , Exp. Date 5/21/2016 ; Service Code 2T8255 , Lot Number 160610032C , Exp. Date 5/22/2016 ; Service Code 2T8255 , Lot Number 160700030C , Exp. Date 5/30/2016 ; Service Code 2T8255 , Lot Number 160700031C , Exp. Date 5/31/2016 ; Service Code 2T8255 , Lot Number 160740060C , Exp. Date 6/4/2016 ; Service Code 2T8255 , Lot Number 160770034C , Exp. Date 6/7/2016 ; Service Code 2T8255 , Lot Number 160830059C , Exp. Date 6/13/2016 ; Service Code 2T8255 , Lot Number 160880040C , Exp. Date 6/18/2016 ; Service Code 2T8255 , Lot Number 160880041C , Exp. Date 6/18/2016 ; Service Code 2T8255 , Lot Number 160940029C , Exp. Date 6/24/2016 ; Service Code 2T8255 , Lot Number 160950051C , Exp. Date 6/25/2016 ;
Pharmedium Services, LLC is recalling 2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 20 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