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
4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC 61553-211-08), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2H8126, Lot Number 161080146M, Exp. Date 7/17/2016, Service Code 2K8127, Lot Number 160460115M, Exp. Date 5/10/2016, Service Code 2K8127, Lot Number 160560222M, Exp. Date 5/20/2016, Service Code 2K8127, Lot Number 160610209M, Exp. Date 5/25/2016, Service Code 2K8127, Lot Number 160620148M, Exp. Date 5/26/2016, Service Code 2K8127, Lot Number 160660062M, Exp. Date 5/29/2016, Service Code 2K8127, Lot Number 160680154M, Exp. Date 6/1/2016, Service Code 2K8127, Lot Number 160690126M, Exp. Date 6/2/2016, Service Code 2K8127, Lot Number 160740153M, Exp. Date 6/7/2016, Service Code 2K8127, Lot Number 160800064M, Exp. Date 6/12/2016, Service Code 2K8127, Lot Number 160810161M, Exp. Date 6/14/2016, Service Code 2K8127, Lot Number 160880187M, Exp. Date 6/21/2016, Service Code 2K8127, Lot Number 160950226M, Exp. Date 6/28/2016, Service Code 2K8127, Lot Number 160960154M, Exp. Date 6/29/2016, Service Code 2K8211, Lot Number 160530215M, Exp. Date 5/23/2016, Service Code 2K8211, Lot Number 160590067M, Exp. Date 5/29/2016, Service Code 2K8211, Lot Number 160750033M, Exp. Date 6/13/2016, Service Code 2K8211, Lot Number 160880261M, Exp. Date 6/27/2016, Service Code 2K8211, Lot Number 160910039M, Exp. Date 6/29/2016
Products Sold
Service Code 2H8126 , Lot Number 161080146M , Exp. Date 7/17/2016 ; Service Code 2K8127 , Lot Number 160460115M , Exp. Date 5/10/2016 ; Service Code 2K8127 , Lot Number 160560222M , Exp. Date 5/20/2016 ; Service Code 2K8127 , Lot Number 160610209M , Exp. Date 5/25/2016 ; Service Code 2K8127 , Lot Number 160620148M , Exp. Date 5/26/2016 ; Service Code 2K8127 , Lot Number 160660062M , Exp. Date 5/29/2016 ; Service Code 2K8127 , Lot Number 160680154M , Exp. Date 6/1/2016 ; Service Code 2K8127 , Lot Number 160690126M , Exp. Date 6/2/2016 ; Service Code 2K8127 , Lot Number 160740153M , Exp. Date 6/7/2016 ; Service Code 2K8127 , Lot Number 160800064M , Exp. Date 6/12/2016 ; Service Code 2K8127 , Lot Number 160810161M , Exp. Date 6/14/2016 ; Service Code 2K8127 , Lot Number 160880187M , Exp. Date 6/21/2016 ; Service Code 2K8127 , Lot Number 160950226M , Exp. Date 6/28/2016 ; Service Code 2K8127 , Lot Number 160960154M , Exp. Date 6/29/2016 ; Service Code 2K8211 , Lot Number 160530215M , Exp. Date 5/23/2016 ; Service Code 2K8211 , Lot Number 160590067M , Exp. Date 5/29/2016 ; Service Code 2K8211 , Lot Number 160750033M , Exp. Date 6/13/2016 ; Service Code 2K8211 , Lot Number 160880261M , Exp. Date 6/27/2016 ; Service Code 2K8211 , Lot Number 160910039M , Exp. Date 6/29/2016 ;
Pharmedium Services, LLC is recalling 4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 2 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