Fentanyl Citrate and Bupivacaine HCl (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
5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8287 (NDC 61553-287-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8287 (NDC 61553-287-02), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2H8287, Lot Number 160390110M, Exp. Date 5/9/2016, Service Code 2H8287, Lot Number 160450123M, Exp. Date 5/15/2016, Service Code 2H8287, Lot Number 160470115M, Exp. Date 5/17/2016, Service Code 2H8287, Lot Number 160600178M, Exp. Date 5/30/2016, Service Code 2H8287, Lot Number 160750128M, Exp. Date 6/14/2016, Service Code 2H8287, Lot Number 160800058M, Exp. Date 6/18/2016, Service Code 2H8287, Lot Number 160820110M, Exp. Date 6/20/2016, Service Code 2H8287, Lot Number 160960130M, Exp. Date 7/5/2016, Service Code 2H8287, Lot Number 160970119M, Exp. Date 7/6/2016, Service Code 2K8287, Lot Number 160530140M, Exp. Date 5/17/2016, Service Code 2K8287, Lot Number 160630194M, Exp. Date 5/27/2016, Service Code 2K8287, Lot Number 160680251M, Exp. Date 6/1/2016, Service Code 2K8287, Lot Number 160760045M, Exp. Date 6/8/2016, Service Code 2K8287, Lot Number 160770044M, Exp. Date 6/9/2016, Service Code 2K8287, Lot Number 160770117M, Exp. Date 6/10/2016, Service Code 2K8287, Lot Number 160940055M, Exp. Date 6/26/2016, Service Code 2K8287, Lot Number 160960048M, Exp. Date 6/28/2016, Service Code 2K8811, Lot Number 160490167M, Exp. Date 5/9/2016, Service Code 2K8811, Lot Number 160530310M, Exp. Date 5/14/2016, Service Code 2K8811, Lot Number 160600078M, Exp. Date 5/20/2016, Service Code 2K8811, Lot Number 160630029M, Exp. Date 5/23/2016, Service Code 2K8811, Lot Number 160670255M, Exp. Date 5/28/2016, Service Code 2K8811, Lot Number 160750239M, Exp. Date 6/5/2016, Service Code 2K8811, Lot Number 160810296M, Exp. Date 6/11/2016, Service Code 2K8811, Lot Number 160950247M, Exp. Date 6/25/2016, Service Code 2K8873, Lot Number 160680043C, Exp. Date 5/29/2016, Service Code 2K8873, Lot Number 160840036C, Exp. Date 6/14/2016, Service Code 2K8873, Lot Number 160870015C, Exp. Date 6/17/2016, Service Code 2K8873, Lot Number 160960052C, Exp. Date 6/26/2016
Products Sold
Service Code 2H8287 , Lot Number 160390110M , Exp. Date 5/9/2016 ; Service Code 2H8287 , Lot Number 160450123M , Exp. Date 5/15/2016 ; Service Code 2H8287 , Lot Number 160470115M , Exp. Date 5/17/2016 ; Service Code 2H8287 , Lot Number 160600178M , Exp. Date 5/30/2016 ; Service Code 2H8287 , Lot Number 160750128M , Exp. Date 6/14/2016 ; Service Code 2H8287 , Lot Number 160800058M , Exp. Date 6/18/2016 ; Service Code 2H8287 , Lot Number 160820110M , Exp. Date 6/20/2016 ; Service Code 2H8287 , Lot Number 160960130M , Exp. Date 7/5/2016 ; Service Code 2H8287 , Lot Number 160970119M , Exp. Date 7/6/2016 ; Service Code 2K8287 , Lot Number 160530140M , Exp. Date 5/17/2016 ; Service Code 2K8287 , Lot Number 160630194M , Exp. Date 5/27/2016 ; Service Code 2K8287 , Lot Number 160680251M , Exp. Date 6/1/2016 ; Service Code 2K8287 , Lot Number 160760045M , Exp. Date 6/8/2016 ; Service Code 2K8287 , Lot Number 160770044M , Exp. Date 6/9/2016 ; Service Code 2K8287 , Lot Number 160770117M , Exp. Date 6/10/2016 ; Service Code 2K8287 , Lot Number 160940055M , Exp. Date 6/26/2016 ; Service Code 2K8287 , Lot Number 160960048M , Exp. Date 6/28/2016 ; Service Code 2K8811 , Lot Number 160490167M , Exp. Date 5/9/2016 ; Service Code 2K8811 , Lot Number 160530310M , Exp. Date 5/14/2016 ; Service Code 2K8811 , Lot Number 160600078M , Exp. Date 5/20/2016 ; Service Code 2K8811 , Lot Number 160630029M , Exp. Date 5/23/2016 ; Service Code 2K8811 , Lot Number 160670255M , Exp. Date 5/28/2016 ; Service Code 2K8811 , Lot Number 160750239M , Exp. Date 6/5/2016 ; Service Code 2K8811 , Lot Number 160810296M , Exp. Date 6/11/2016 ; Service Code 2K8811 , Lot Number 160950247M , Exp. Date 6/25/2016 ; Service Code 2K8873 , Lot Number 160680043C , Exp. Date 5/29/2016 ; Service Code 2K8873 , Lot Number 160840036C , Exp. Date 6/14/2016 ; Service Code 2K8873 , Lot Number 160870015C , Exp. Date 6/17/2016 ; Service Code 2K8873 , Lot Number 160960052C , Exp. Date 6/26/2016 ;
Pharmedium Services, LLC is recalling 5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 25 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