Bupivacaine HCl 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
0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Lot Number 160380121M, Exp. Date 5/7/2016, Lot Number 160420113M, Exp. Date 5/11/2016, Lot Number 160450116M, Exp. Date 5/15/2016, Lot Number 160470127M, Exp. Date 5/16/2016, Lot Number 160480136M, Exp. Date 5/18/2016, Lot Number 160490132M, Exp. Date 5/18/2016, Lot Number 160520114M, Exp. Date 5/21/2016, Lot Number 160530129M, Exp. Date 5/23/2016, Lot Number 160590138M, Exp. Date 5/29/2016, Lot Number 160600038C, Exp. Date 5/30/2016, Lot Number 160620018C, Exp. Date 6/1/2016, Lot Number 160700020C, Exp. Date 6/9/2016, Lot Number 160740044C, Exp. Date 6/13/2016, Lot Number 160750033C, Exp. Date 6/14/2016, Lot Number 160760051C, Exp. Date 6/15/2016, Lot Number 160770024C, Exp. Date 6/16/2016, Lot Number 160810053C, Exp. Date 6/20/2016, Lot Number 160820033C, Exp. Date 6/21/2016, Lot Number 160880014C, Exp. Date 6/27/2016, Lot Number 160940015C, Exp. Date 7/2/2016, Lot Number 160950034C, Exp. Date 7/4/2016, Lot Number 160960019C, Exp. Date 7/5/2016
Products Sold
Lot Number 160380121M , Exp. Date 5/7/2016 ; Lot Number 160420113M , Exp. Date 5/11/2016 ; Lot Number 160450116M , Exp. Date 5/15/2016 ; Lot Number 160470127M , Exp. Date 5/16/2016 ; Lot Number 160480136M , Exp. Date 5/18/2016 ; Lot Number 160490132M , Exp. Date 5/18/2016 ; Lot Number 160520114M , Exp. Date 5/21/2016 ; Lot Number 160530129M , Exp. Date 5/23/2016 ; Lot Number 160590138M , Exp. Date 5/29/2016 ; Lot Number 160600038C , Exp. Date 5/30/2016 ; Lot Number 160620018C , Exp. Date 6/1/2016 ; Lot Number 160700020C , Exp. Date 6/9/2016 ; Lot Number 160740044C , Exp. Date 6/13/2016 ; Lot Number 160750033C , Exp. Date 6/14/2016 ; Lot Number 160760051C , Exp. Date 6/15/2016 ; Lot Number 160770024C , Exp. Date 6/16/2016 ; Lot Number 160810053C , Exp. Date 6/20/2016 ; Lot Number 160820033C , Exp. Date 6/21/2016 ; Lot Number 160880014C , Exp. Date 6/27/2016 ; Lot Number 160940015C , Exp. Date 7/2/2016 ; Lot Number 160950034C , Exp. Date 7/4/2016 ; Lot Number 160960019C , Exp. Date 7/5/2016 ;
Pharmedium Services, LLC is recalling 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Me 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