Fentanyl Bupivacaine Solution (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
1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection Service Code 2T8878 100 ml in 100 ml Yellow Smiths Medical Cassette, flow stop free-flow protection ((NDC 61553-878-52), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2T8232, Lot Number 160970019C, Exp. Date 5/7/2016, Service Code 2T8878, Lot Number 160450193M, Exp. Date 5/6/2016, Service Code 2T8878, Lot Number 160470227M, Exp. Date 5/8/2016, Service Code 2T8878, Lot Number 160590187M, Exp. Date 5/19/2016, Service Code 2T8878, Lot Number 160630026M, Exp. Date 5/23/2016, Service Code 2T8878, Lot Number 160700162M, Exp. Date 5/31/2016, Service Code 2T8878, Lot Number 160710004M, Exp. Date 5/31/2016, Service Code 2T8878, Lot Number 160740228M, Exp. Date 6/4/2016, Service Code 2T8878, Lot Number 160750111M, Exp. Date 6/4/2016, Service Code 2T8878, Lot Number 160900226M, Exp. Date 6/20/2016, Service Code 2T8878, Lot Number 161080176M, Exp. Date 7/8/2016
Products Sold
Service Code 2T8232 , Lot Number 160970019C , Exp. Date 5/7/2016 ; Service Code 2T8878 , Lot Number 160450193M , Exp. Date 5/6/2016 ; Service Code 2T8878 , Lot Number 160470227M , Exp. Date 5/8/2016 ; Service Code 2T8878 , Lot Number 160590187M , Exp. Date 5/19/2016 ; Service Code 2T8878 , Lot Number 160630026M , Exp. Date 5/23/2016 ; Service Code 2T8878 , Lot Number 160700162M , Exp. Date 5/31/2016 ; Service Code 2T8878 , Lot Number 160710004M , Exp. Date 5/31/2016 ; Service Code 2T8878 , Lot Number 160740228M , Exp. Date 6/4/2016 ; Service Code 2T8878 , Lot Number 160750111M , Exp. Date 6/4/2016 ; Service Code 2T8878 , Lot Number 160900226M , Exp. Date 6/20/2016 ; Service Code 2T8878 , Lot Number 161080176M , Exp. Date 7/8/2016 ;
Pharmedium Services, LLC is recalling 1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 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