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 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9232, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-032-95
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Lot Number 160460204M, Exp. Date 5/10/2016, Lot Number 160560170M, Exp. Date 5/20/2016, Lot Number 160700007M, Exp. Date 6/2/2016, Lot Number 160810176M, Exp. Date 6/14/2016, Lot Number 160830325M, Exp. Date 6/16/2016, Lot Number 160880270M, Exp. Date 6/21/2016, Lot Number 160890245M, Exp. Date 6/22/2016, Lot Number 160900144M, Exp. Date 6/23/2016, Lot Number 160950241M, Exp. Date 6/28/2016, Lot Number 161080135M, Exp. Date 7/11/2016
Products Sold
Lot Number 160460204M , Exp. Date 5/10/2016 ; Lot Number 160560170M , Exp. Date 5/20/2016 ; Lot Number 160700007M , Exp. Date 6/2/2016 ; Lot Number 160810176M , Exp. Date 6/14/2016 ; Lot Number 160830325M , Exp. Date 6/16/2016 ; Lot Number 160880270M , Exp. Date 6/21/2016 ; Lot Number 160890245M , Exp. Date 6/22/2016 ; Lot Number 160900144M , Exp. Date 6/23/2016 ; Lot Number 160950241M , Exp. Date 6/28/2016 ; Lot Number 161080135M , Exp. Date 7/11/2016 ;
Pharmedium Services, LLC is recalling 1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 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