Fentanyl Bupivacaine Injection (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
3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8180 (NDC 61553-180-52), 250 mL in 250 mL Hospira LifeCare Bag Service Code 2H8262 (NDC 61553-262-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8180 (NDC 61553-180-02), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2H8180, Lot Number 160450152M, Exp. Date 5/11/2016, Service Code 2H8180, Lot Number 160830040M, Exp. Date 6/17/2016, Service Code 2H8262, Lot Number 160380102M, Exp. Date 5/8/2016, Service Code 2H8262, Lot Number 160750131M, Exp. Date 6/14/2016, Service Code 2H8262, Lot Number 161080121M, Exp. Date 7/17/2016, Service Code 2K8180, Lot Number 160460038C, Exp. Date 5/10/2016, Service Code 2K8180, Lot Number 160480026C, Exp. Date 5/12/2016, Service Code 2K8180, Lot Number 160550022C, Exp. Date 5/19/2016, Service Code 2K8180, Lot Number 160620021C, Exp. Date 5/26/2016, Service Code 2K8180, Lot Number 160680038C, Exp. Date 6/1/2016, Service Code 2K8180, Lot Number 160760022C, Exp. Date 6/9/2016, Service Code 2K8180, Lot Number 160770042C, Exp. Date 6/10/2016, Service Code 2K8180, Lot Number 160830034C, Exp. Date 6/16/2016, Service Code 2K8180, Lot Number 160900094C, Exp. Date 6/23/2016, Service Code 2K8180, Lot Number 160940033C, Exp. Date 6/27/2016, Service Code 2K8180, Lot Number 160970035C, Exp. Date 6/30/2016, Service Code 2K8905, Lot Number 160810187M, Exp. Date 6/11/2016, Service Code 2K8905, Lot Number 160890186M, Exp. Date 6/18/2016, Service Code 2K8975, Lot Number 160550132M, Exp. Date 5/15/2016, Service Code 2K8975, Lot Number 160610229M, Exp. Date 5/22/2016, Service Code 2K8975, Lot Number 160770165M, Exp. Date 6/7/2016
Products Sold
Service Code 2H8180 , Lot Number 160450152M , Exp. Date 5/11/2016 ; Service Code 2H8180 , Lot Number 160830040M , Exp. Date 6/17/2016 ; Service Code 2H8262 , Lot Number 160380102M , Exp. Date 5/8/2016 ; Service Code 2H8262 , Lot Number 160750131M , Exp. Date 6/14/2016 ; Service Code 2H8262 , Lot Number 161080121M , Exp. Date 7/17/2016 ; Service Code 2K8180 , Lot Number 160460038C , Exp. Date 5/10/2016 ; Service Code 2K8180 , Lot Number 160480026C , Exp. Date 5/12/2016 ; Service Code 2K8180 , Lot Number 160550022C , Exp. Date 5/19/2016 ; Service Code 2K8180 , Lot Number 160620021C , Exp. Date 5/26/2016 ; Service Code 2K8180 , Lot Number 160680038C , Exp. Date 6/1/2016 ; Service Code 2K8180 , Lot Number 160760022C , Exp. Date 6/9/2016 ; Service Code 2K8180 , Lot Number 160770042C , Exp. Date 6/10/2016 ; Service Code 2K8180 , Lot Number 160830034C , Exp. Date 6/16/2016 ; Service Code 2K8180 , Lot Number 160900094C , Exp. Date 6/23/2016 ; Service Code 2K8180 , Lot Number 160940033C , Exp. Date 6/27/2016 ; Service Code 2K8180 , Lot Number 160970035C , Exp. Date 6/30/2016 ; Service Code 2K8905 , Lot Number 160810187M , Exp. Date 6/11/2016 ; Service Code 2K8905 , Lot Number 160890186M , Exp. Date 6/18/2016 ; Service Code 2K8975 , Lot Number 160550132M , Exp. Date 5/15/2016 ; Service Code 2K8975 , Lot Number 160610229M , Exp. Date 5/22/2016 ; Service Code 2K8975 , Lot Number 160770165M , Exp. Date 6/7/2016 ;
Pharmedium Services, LLC is recalling 3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 1 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