Fentanyl Citrate Bupivacaine (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
3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag, Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8284 (NDC 61553-284-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2H8239, Lot Number 160400232M, Exp. Date 5/10/2016, Service Code 2H8239, Lot Number 160630193M, Exp. Date 6/2/2016, Service Code 2K8239, Lot Number 160520143M, Exp. Date 5/16/2016, Service Code 2K8239, Lot Number 160530306M, Exp. Date 5/17/2016, Service Code 2K8239, Lot Number 160610250M, Exp. Date 5/25/2016, Service Code 2K8239, Lot Number 160630167M, Exp. Date 5/27/2016, Service Code 2K8239, Lot Number 160680214M, Exp. Date 6/1/2016, Service Code 2K8239, Lot Number 160750241M, Exp. Date 6/8/2016, Service Code 2K8239, Lot Number 160820181M, Exp. Date 6/15/2016, Service Code 2K8239, Lot Number 160840225M, Exp. Date 6/17/2016, Service Code 2K8239, Lot Number 160900186M, Exp. Date 6/23/2016, Service Code 2K8239, Lot Number 160940234M, Exp. Date 6/27/2016, Service Code 2K8239, Lot Number 161080183M, Exp. Date 7/11/2016, Service Code 2K8284, Lot Number 160470223M, Exp. Date 5/17/2016, Service Code 2K8284, Lot Number 160520118M, Exp. Date 5/22/2016, Service Code 2K8284, Lot Number 160610207M, Exp. Date 5/31/2016, Service Code 2K8284, Lot Number 160620153M, Exp. Date 6/1/2016, Service Code 2K8284, Lot Number 160750236M, Exp. Date 6/14/2016, Service Code 2K8284, Lot Number 160770226M, Exp. Date 6/16/2016, Service Code 2K8284, Lot Number 160840209M, Exp. Date 6/23/2016, Service Code 2K8284, Lot Number 160910218M, Exp. Date 6/30/2016, Service Code 2K8284, Lot Number 160960157M, Exp. Date 7/5/2016, Service Code 2K8284, Lot Number 161080227M, Exp. Date 7/17/2016
Products Sold
Service Code 2H8239 , Lot Number 160400232M , Exp. Date 5/10/2016 ; Service Code 2H8239 , Lot Number 160630193M , Exp. Date 6/2/2016 ; Service Code 2K8239 , Lot Number 160520143M , Exp. Date 5/16/2016 ; Service Code 2K8239 , Lot Number 160530306M , Exp. Date 5/17/2016 ; Service Code 2K8239 , Lot Number 160610250M , Exp. Date 5/25/2016 ; Service Code 2K8239 , Lot Number 160630167M , Exp. Date 5/27/2016 ; Service Code 2K8239 , Lot Number 160680214M , Exp. Date 6/1/2016 ; Service Code 2K8239 , Lot Number 160750241M , Exp. Date 6/8/2016 ; Service Code 2K8239 , Lot Number 160820181M , Exp. Date 6/15/2016 ; Service Code 2K8239 , Lot Number 160840225M , Exp. Date 6/17/2016 ; Service Code 2K8239 , Lot Number 160900186M , Exp. Date 6/23/2016 ; Service Code 2K8239 , Lot Number 160940234M , Exp. Date 6/27/2016 ; Service Code 2K8239 , Lot Number 161080183M , Exp. Date 7/11/2016 ; Service Code 2K8284 , Lot Number 160470223M , Exp. Date 5/17/2016 ; Service Code 2K8284 , Lot Number 160520118M , Exp. Date 5/22/2016 ; Service Code 2K8284 , Lot Number 160610207M , Exp. Date 5/31/2016 ; Service Code 2K8284 , Lot Number 160620153M , Exp. Date 6/1/2016 ; Service Code 2K8284 , Lot Number 160750236M , Exp. Date 6/14/2016 ; Service Code 2K8284 , Lot Number 160770226M , Exp. Date 6/16/2016 ; Service Code 2K8284 , Lot Number 160840209M , Exp. Date 6/23/2016 ; Service Code 2K8284 , Lot Number 160910218M , Exp. Date 6/30/2016 ; Service Code 2K8284 , Lot Number 160960157M , Exp. Date 7/5/2016 ; Service Code 2K8284 , Lot Number 161080227M , Exp. Date 7/17/2016 ;
Pharmedium Services, LLC is recalling 3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 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