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 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8296 (NDC 61553-296-52), 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8296 (NDC 61553-296-22), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ,
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2H8296, Lot Number 160420192M, Exp. Date 5/8/2016, Service Code 2H8296, Lot Number 160450199M, Exp. Date 5/11/2016, Service Code 2H8296, Lot Number 160490146M, Exp. Date 5/15/2016, Service Code 2H8296, Lot Number 160590180M, Exp. Date 5/25/2016, Service Code 2H8296, Lot Number 160660231M, Exp. Date 6/1/2016, Service Code 2H8296, Lot Number 160700136M, Exp. Date 6/5/2016, Service Code 2H8296, Lot Number 160770233M, Exp. Date 6/12/2016, Service Code 2H8296, Lot Number 160820140M, Exp. Date 6/17/2016, Service Code 2H8296, Lot Number 160880282M, Exp. Date 6/23/2016, Service Code 2H8296, Lot Number 160910131M, Exp. Date 6/26/2016, Service Code 2H8296, Lot Number 160970117M, Exp. Date 7/1/2016, Service Code 2H8296, Lot Number 161080157M, Exp. Date 7/13/2016, Service Code 2K8296, Lot Number 160420191M, Exp. Date 5/12/2016, Service Code 2K8296, Lot Number 160480230M, Exp. Date 5/18/2016, Service Code 2K8296, Lot Number 160540227M, Exp. Date 5/24/2016, Service Code 2K8296, Lot Number 160610205M, Exp. Date 5/31/2016, Service Code 2K8296, Lot Number 160670249M, Exp. Date 6/6/2016, Service Code 2K8296, Lot Number 160830181M, Exp. Date 6/22/2016, Service Code 2K8296, Lot Number 160840213M, Exp. Date 6/23/2016, Service Code 2T6296, Lot Number 160450196M, Exp. Date 5/15/2016, Service Code 2T6296, Lot Number 160530159M, Exp. Date 5/23/2016, Service Code 2T6296, Lot Number 160690195M, Exp. Date 6/8/2016, Service Code 2T6296, Lot Number 160750219M, Exp. Date 6/14/2016, Service Code 2T6296, Lot Number 160810166M, Exp. Date 6/20/2016, Service Code 2T6296, Lot Number 160880176M, Exp. Date 6/26/2016, Service Code 2T6296, Lot Number 160940048M, Exp. Date 7/2/2016, Service Code 2T6296, Lot Number 160970123M, Exp. Date 7/5/2016
Products Sold
Service Code 2H8296 , Lot Number 160420192M , Exp. Date 5/8/2016 ; Service Code 2H8296 , Lot Number 160450199M , Exp. Date 5/11/2016 ; Service Code 2H8296 , Lot Number 160490146M , Exp. Date 5/15/2016 ; Service Code 2H8296 , Lot Number 160590180M , Exp. Date 5/25/2016 ; Service Code 2H8296 , Lot Number 160660231M , Exp. Date 6/1/2016 ; Service Code 2H8296 , Lot Number 160700136M , Exp. Date 6/5/2016 ; Service Code 2H8296 , Lot Number 160770233M , Exp. Date 6/12/2016 ; Service Code 2H8296 , Lot Number 160820140M , Exp. Date 6/17/2016 ; Service Code 2H8296 , Lot Number 160880282M , Exp. Date 6/23/2016 ; Service Code 2H8296 , Lot Number 160910131M , Exp. Date 6/26/2016 ; Service Code 2H8296 , Lot Number 160970117M , Exp. Date 7/1/2016 ; Service Code 2H8296 , Lot Number 161080157M , Exp. Date 7/13/2016 ; Service Code 2K8296 , Lot Number 160420191M , Exp. Date 5/12/2016 ; Service Code 2K8296 , Lot Number 160480230M , Exp. Date 5/18/2016 ; Service Code 2K8296 , Lot Number 160540227M , Exp. Date 5/24/2016 ; Service Code 2K8296 , Lot Number 160610205M , Exp. Date 5/31/2016 ; Service Code 2K8296 , Lot Number 160670249M , Exp. Date 6/6/2016 ; Service Code 2K8296 , Lot Number 160830181M , Exp. Date 6/22/2016 ; Service Code 2K8296 , Lot Number 160840213M , Exp. Date 6/23/2016 ; Service Code 2T6296 , Lot Number 160450196M , Exp. Date 5/15/2016 ; Service Code 2T6296 , Lot Number 160530159M , Exp. Date 5/23/2016 ; Service Code 2T6296 , Lot Number 160690195M , Exp. Date 6/8/2016 ; Service Code 2T6296 , Lot Number 160750219M , Exp. Date 6/14/2016 ; Service Code 2T6296 , Lot Number 160810166M , Exp. Date 6/20/2016 ; Service Code 2T6296 , Lot Number 160880176M , Exp. Date 6/26/2016 ; Service Code 2T6296 , Lot Number 160940048M , Exp. Date 7/2/2016 ; Service Code 2T6296 , Lot Number 160970123M , Exp. Date 7/5/2016 ;
Pharmedium Services, LLC is recalling 2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 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