Fentanyl Citrate with Bupivacaine (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
10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Lot Number 160460189M, Exp. Date 5/10/2016, Lot Number 160480179M, Exp. Date 5/12/2016, Lot Number 160520105M, Exp. Date 5/15/2016, Lot Number 160530291M, Exp. Date 5/17/2016, Lot Number 160540130M, Exp. Date 5/17/2016, Lot Number 160550186M, Exp. Date 5/19/2016, Lot Number 160560087M, Exp. Date 5/19/2016, Lot Number 160590074M, Exp. Date 5/23/2016, Lot Number 160620037M, Exp. Date 5/25/2016, Lot Number 160630028M, Exp. Date 5/26/2016, Lot Number 160660039M, Exp. Date 5/29/2016, Lot Number 160730059M, Exp. Date 6/6/2016, Lot Number 160740234M, Exp. Date 6/7/2016, Lot Number 160800073M, Exp. Date 6/12/2016, Lot Number 160820049M, Exp. Date 6/14/2016, Lot Number 160890045M, Exp. Date 6/21/2016, Lot Number 160970197M, Exp. Date 6/30/2016
Products Sold
Lot Number 160460189M , Exp. Date 5/10/2016 ; Lot Number 160480179M , Exp. Date 5/12/2016 ; Lot Number 160520105M , Exp. Date 5/15/2016 ; Lot Number 160530291M , Exp. Date 5/17/2016 ; Lot Number 160540130M , Exp. Date 5/17/2016 ; Lot Number 160550186M , Exp. Date 5/19/2016 ; Lot Number 160560087M , Exp. Date 5/19/2016 ; Lot Number 160590074M , Exp. Date 5/23/2016 ; Lot Number 160620037M , Exp. Date 5/25/2016 ; Lot Number 160630028M , Exp. Date 5/26/2016 ; Lot Number 160660039M , Exp. Date 5/29/2016 ; Lot Number 160730059M , Exp. Date 6/6/2016 ; Lot Number 160740234M , Exp. Date 6/7/2016 ; Lot Number 160800073M , Exp. Date 6/12/2016 ; Lot Number 160820049M , Exp. Date 6/14/2016 ; Lot Number 160890045M , Exp. Date 6/21/2016 ; Lot Number 160970197M , Exp. Date 6/30/2016 ;
Pharmedium Services, LLC is recalling 10 mcg/mL Fentanyl Citrate and 0.1% 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