Fentanyl Citrate and Bupivacaine HCl (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
1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2K9998, Lot Number 160460135M, Exp. Date 5/10/2016, Service Code 2K9998, Lot Number 160530146M, Exp. Date 5/17/2016, Service Code 2K9998, Lot Number 160590137M, Exp. Date 5/23/2016, Service Code 2K9998, Lot Number 160660221M, Exp. Date 5/30/2016, Service Code 2K9998, Lot Number 160730163M, Exp. Date 6/6/2016, Service Code 2K9998, Lot Number 160870147M, Exp. Date 6/20/2016, Service Code 2K9998, Lot Number 160880265M, Exp. Date 6/21/2016, Service Code 2K9998, Lot Number 160940206M, Exp. Date 6/27/2016, Service Code 2K9998, Lot Number 161080210M, Exp. Date 7/11/2016, Service Code 2T8998, Lot Number 160460267M, Exp. Date 5/7/2016, Service Code 2T8998, Lot Number 160470042M, Exp. Date 5/8/2016, Service Code 2T8998, Lot Number 160530034M, Exp. Date 5/14/2016, Service Code 2T8998, Lot Number 160610043M, Exp. Date 5/22/2016, Service Code 2T8998, Lot Number 160640008M, Exp. Date 5/24/2016, Service Code 2T8998, Lot Number 160690011C, Exp. Date 5/30/2016, Service Code 2T8998, Lot Number 160690012C, Exp. Date 5/30/2016, Service Code 2T8998, Lot Number 160740064C, Exp. Date 6/4/2016, Service Code 2T8998, Lot Number 160810066C, Exp. Date 6/11/2016, Service Code 2T8998, Lot Number 160840030C, Exp. Date 6/14/2016, Service Code 2T8998, Lot Number 160880042C, Exp. Date 6/18/2016, Service Code 2T8998, Lot Number 160880043C, Exp. Date 6/18/2016, Service Code 2T8998, Lot Number 160910014C, Exp. Date 6/21/2016, Service Code 2T8998, Lot Number 160910015C, Exp. Date 6/21/2016, Service Code 2T8998, Lot Number 160950071C, Exp. Date 6/25/2016
Products Sold
Service Code 2K9998 , Lot Number 160460135M , Exp. Date 5/10/2016 ; Service Code 2K9998 , Lot Number 160530146M , Exp. Date 5/17/2016 ; Service Code 2K9998 , Lot Number 160590137M , Exp. Date 5/23/2016 ; Service Code 2K9998 , Lot Number 160660221M , Exp. Date 5/30/2016 ; Service Code 2K9998 , Lot Number 160730163M , Exp. Date 6/6/2016 ; Service Code 2K9998 , Lot Number 160870147M , Exp. Date 6/20/2016 ; Service Code 2K9998 , Lot Number 160880265M , Exp. Date 6/21/2016 ; Service Code 2K9998 , Lot Number 160940206M , Exp. Date 6/27/2016 ; Service Code 2K9998 , Lot Number 161080210M , Exp. Date 7/11/2016 ; Service Code 2T8998 , Lot Number 160460267M , Exp. Date 5/7/2016 ; Service Code 2T8998 , Lot Number 160470042M , Exp. Date 5/8/2016 ; Service Code 2T8998 , Lot Number 160530034M , Exp. Date 5/14/2016 ; Service Code 2T8998 , Lot Number 160610043M , Exp. Date 5/22/2016 ; Service Code 2T8998 , Lot Number 160640008M , Exp. Date 5/24/2016 ; Service Code 2T8998 , Lot Number 160690011C , Exp. Date 5/30/2016 ; Service Code 2T8998 , Lot Number 160690012C , Exp. Date 5/30/2016 ; Service Code 2T8998 , Lot Number 160740064C , Exp. Date 6/4/2016 ; Service Code 2T8998 , Lot Number 160810066C , Exp. Date 6/11/2016 ; Service Code 2T8998 , Lot Number 160840030C , Exp. Date 6/14/2016 ; Service Code 2T8998 , Lot Number 160880042C , Exp. Date 6/18/2016 ; Service Code 2T8998 , Lot Number 160880043C , Exp. Date 6/18/2016 ; Service Code 2T8998 , Lot Number 160910014C , Exp. Date 6/21/2016 ; Service Code 2T8998 , Lot Number 160910015C , Exp. Date 6/21/2016 ; Service Code 2T8998 , Lot Number 160950071C , Exp. Date 6/25/2016 ;
Pharmedium Services, LLC is recalling 1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 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