Bupivacaine HCl Injectable (Pharmedium) – Glass Particulate (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
0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120 , NDC 61553-120-50 , 250 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2H8243 , NDC 61553-243-54 , 200 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2K8120 , NDC 61553-120-09 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2K8243 , NDC 61553-243-37 , 200 ml in 250 ml Baxter Intravia Bag ; , Service Code 2K9120 , NDC 61553-120-03 , 500 ml in 500 ml Baxter Intravia Bag ; , Service C
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2H8120, Lot Number 160380137M, Exp. Date 5/8/2016, Service Code 2H8120, Lot Number 160420181M, Exp. Date 5/12/2016, Service Code 2H8120, Lot Number 160450166M, Exp. Date 5/15/2016, Service Code 2H8120, Lot Number 160460209M, Exp. Date 5/16/2016, Service Code 2H8120, Lot Number 160600277M, Exp. Date 5/30/2016, Service Code 2H8120, Lot Number 160610057M, Exp. Date 5/30/2016, Service Code 2H8120, Lot Number 160610224M, Exp. Date 5/31/2016, Service Code 2H8120, Lot Number 160680153M, Exp. Date 6/7/2016, Service Code 2H8120, Lot Number 160810219M, Exp. Date 6/20/2016, Service Code 2H8120, Lot Number 160910124M, Exp. Date 6/29/2016, Service Code 2H8120, Lot Number 160960220M, Exp. Date 7/5/2016, Service Code 2H8243, Lot Number 160530200M, Exp. Date 5/9/2016, Service Code 2H8243, Lot Number 160600047M, Exp. Date 5/16/2016, Service Code 2H8243, Lot Number 160670033M, Exp. Date 5/22/2016, Service Code 2H8243, Lot Number 160810051M, Exp. Date 6/5/2016, Service Code 2H8243, Lot Number 160880267M, Exp. Date 6/13/2016, Service Code 2H8243, Lot Number 160910035M, Exp. Date 6/15/2016, Service Code 2H8243, Lot Number 160950059M, Exp. Date 6/19/2016, Service Code 2K8120, Lot Number 160480190M, Exp. Date 5/18/2016, Service Code 2K8120, Lot Number 160550194M, Exp. Date 5/25/2016, Service Code 2K8120, Lot Number 160940060M, Exp. Date 7/2/2016, Service Code 2K8243, Lot Number 160410183M, Exp. Date 5/11/2016, Service Code 2K8243, Lot Number 160420152M, Exp. Date 5/12/2016, Service Code 2K8243, Lot Number 160460131M, Exp. Date 5/16/2016, Service Code 2K8243, Lot Number 160490239M, Exp. Date 5/19/2016, Service Code 2K8243, Lot Number 160520184M, Exp. Date 5/22/2016, Service Code 2K8243, Lot Number 160550125M, Exp. Date 5/25/2016, Service Code 2K8243, Lot Number 160590160M, Exp. Date 5/29/2016, Service Code 2K8243, Lot Number 160600171M, Exp. Date 5/30/2016, Service Code 2K8243, Lot Number 160610227M, Exp. Date 5/31/2016, Service Code 2K8243, Lot Number 160620142M, Exp. Date 6/1/2016, Service Code 2K8243, Lot Number 160630199M, Exp. Date 6/2/2016, Service Code 2K8243, Lot Number 160660168M, Exp. Date 6/5/2016, Service Code 2K8243, Lot Number 160670236M, Exp. Date 6/6/2016, Service Code 2K8243, Lot Number 160700192M, Exp. Date 6/9/2016, Service Code 2K8243, Lot Number 160740235M, Exp. Date 6/13/2016, Service Code 2K8243, Lot Number 160760190M, Exp. Date 6/15/2016, Service Code 2K8243, Lot Number 160810280M, Exp. Date 6/20/2016, Service Code 2K8243, Lot Number 160820234M, Exp. Date 6/21/2016, Service Code 2K8243, Lot Number 160830120M, Exp. Date 6/21/2016, Service Code 2K8243, Lot Number 160870168M, Exp. Date 6/26/2016, Service Code 2K8243, Lot Number 160900173M, Exp. Date 6/29/2016, Service Code 2K8243, Lot Number 160910176M, Exp. Date 6/30/2016, Service Code 2K8243, Lot Number 160940041M, Exp. Date 7/2/2016, Service Code 2K8243, Lot Number 161080168M, Exp. Date 7/17/2016, Service Code 2K9120, Lot Number 160380034C, Exp. Date 5/8/2016, Service Code 2K9120, Lot Number 160380105M, Exp. Date 5/8/2016, Service Code 2K9120, Lot Number 160420030C, Exp. Date 5/12/2016, Service Code 2K9120, Lot Number 160470039C, Exp. Date 5/17/2016, Service Code 2K9120, Lot Number 160540034C, Exp. Date 5/24/2016, Service Code 2K9120, Lot Number 160550029C, Exp. Date 5/25/2016, Service Code 2K9120, Lot Number 160590078M, Exp. Date 5/29/2016, Service Code 2K9120, Lot Number 160600067M, Exp. Date 5/29/2016, Service Code 2K9120, Lot Number 160670187M, Exp. Date 6/6/2016, Service Code 2K9120, Lot Number 160730076M, Exp. Date 6/11/2016, Service Code 2K9120, Lot Number 160750233M, Exp. Date 6/14/2016, Service Code 2K9120, Lot Number 160770001M, Exp. Date 6/15/2016, Service Code 2K9120, Lot Number 160770049M, Exp. Date 6/15/2016, Service Code 2K9120, Lot Number 160810056M, Exp. Date 6/19/2016, Service Code 2K9120, Lot Number 160870069M, Exp. Date 6/26/2016, Service Code 2K9120, Lot Number 160910184M, Exp. Date 6/30/2016, Service Code 2K9120, Lot Number 160940154M, Exp. Date 7/3/2016, Service Code 2K9120, Lot Number 160960190M, Exp. Date 7/5/2016, Service Code 2K9120, Lot Number 161080156M, Exp. Date 7/17/2016, Service Code 2N1120, Lot Number 160960241M, Exp. Date 7/5/2016, Service Code 2N9619, Lot Number 160950229M, Exp. Date 7/4/2016, Service Code 2R3317-5, Lot Number 160420122M, Exp. Date 5/12/2016, Service Code 2R3317-5, Lot Number 160550206M, Exp. Date 5/24/2016, Service Code 2R3317-5, Lot Number 160590164M, Exp. Date 5/29/2016, Service Code 2R3317-5, Lot Number 160660159M, Exp. Date 6/5/2016, Service Code 2R3317-5, Lot Number 160690151M, Exp. Date 6/7/2016, Service Code 2R3317-5, Lot Number 160740252M, Exp. Date 6/13/2016, Service Code 2R3317-5, Lot Number 160750181M, Exp. Date 6/14/2016, Service Code 2R3317-5, Lot Number 160810298M, Exp. Date 6/20/2016, Service Code 2R3317-5, Lot Number 160830222M, Exp. Date 6/22/2016, Service Code 2R3317-5, Lot Number 160940150M, Exp. Date 7/3/2016, Service Code 2R3317-5, Lot Number 161080209M, Exp. Date 7/17/2016, Service Code 3317NO, Lot Number 160380157M, Exp. Date 5/8/2016, Service Code 3317NO, Lot Number 160420173M, Exp. Date 5/11/2016, Service Code 3317NO, Lot Number 160540140M, Exp. Date 5/24/2016, Service Code 3317NO, Lot Number 160600185M, Exp. Date 5/30/2016, Service Code 3317NO, Lot Number 160630204M, Exp. Date 6/2/2016, Service Code 3317NO, Lot Number 160660172M, Exp. Date 6/5/2016, Service Code 3317NO, Lot Number 160700219M, Exp. Date 6/9/2016, Service Code 3317NO, Lot Number 160770174M, Exp. Date 6/16/2016, Service Code 3317NO, Lot Number 160840205M, Exp. Date 6/23/2016, Service Code 3317NO, Lot Number 160910210M, Exp. Date 6/30/2016, Service Code 3317NO, Lot Number 161080215M, Exp. Date 7/17/2016
Products Sold
Service Code 2H8120 , Lot Number 160380137M , Exp. Date 5/8/2016 ; Service Code 2H8120 , Lot Number 160420181M , Exp. Date 5/12/2016 ; Service Code 2H8120 , Lot Number 160450166M , Exp. Date 5/15/2016 ; Service Code 2H8120 , Lot Number 160460209M , Exp. Date 5/16/2016 ; Service Code 2H8120 , Lot Number 160600277M , Exp. Date 5/30/2016 ; Service Code 2H8120 , Lot Number 160610057M , Exp. Date 5/30/2016 ; Service Code 2H8120 , Lot Number 160610224M , Exp. Date 5/31/2016 ; Service Code 2H8120 , Lot Number 160680153M , Exp. Date 6/7/2016 ; Service Code 2H8120 , Lot Number 160810219M , Exp. Date 6/20/2016 ; Service Code 2H8120 , Lot Number 160910124M , Exp. Date 6/29/2016 ; Service Code 2H8120 , Lot Number 160960220M , Exp. Date 7/5/2016 ; Service Code 2H8243 , Lot Number 160530200M , Exp. Date 5/9/2016 ; Service Code 2H8243 , Lot Number 160600047M , Exp. Date 5/16/2016 ; Service Code 2H8243 , Lot Number 160670033M , Exp. Date 5/22/2016 ; Service Code 2H8243 , Lot Number 160810051M , Exp. Date 6/5/2016 ; Service Code 2H8243 , Lot Number 160880267M , Exp. Date 6/13/2016 ; Service Code 2H8243 , Lot Number 160910035M , Exp. Date 6/15/2016 ; Service Code 2H8243 , Lot Number 160950059M , Exp. Date 6/19/2016 ; Service Code 2K8120 , Lot Number 160480190M , Exp. Date 5/18/2016 ; Service Code 2K8120 , Lot Number 160550194M , Exp. Date 5/25/2016 ; Service Code 2K8120 , Lot Number 160940060M , Exp. Date 7/2/2016 ; Service Code 2K8243 , Lot Number 160410183M , Exp. Date 5/11/2016 ; Service Code 2K8243 , Lot Number 160420152M , Exp. Date 5/12/2016 ; Service Code 2K8243 , Lot Number 160460131M , Exp. Date 5/16/2016 ; Service Code 2K8243 , Lot Number 160490239M , Exp. Date 5/19/2016 ; Service Code 2K8243 , Lot Number 160520184M , Exp. Date 5/22/2016 ; Service Code 2K8243 , Lot Number 160550125M , Exp. Date 5/25/2016 ; Service Code 2K8243 , Lot Number 160590160M , Exp. Date 5/29/2016 ; Service Code 2K8243 , Lot Number 160600171M , Exp. Date 5/30/2016 ; Service Code 2K8243 , Lot Number 160610227M , Exp. Date 5/31/2016 ; Service Code 2K8243 , Lot Number 160620142M , Exp. Date 6/1/2016 ; Service Code 2K8243 , Lot Number 160630199M , Exp. Date 6/2/2016 ; Service Code 2K8243 , Lot Number 160660168M , Exp. Date 6/5/2016 ; Service Code 2K8243 , Lot Number 160670236M , Exp. Date 6/6/2016 ; Service Code 2K8243 , Lot Number 160700192M , Exp. Date 6/9/2016 ; Service Code 2K8243 , Lot Number 160740235M , Exp. Date 6/13/2016 ; Service Code 2K8243 , Lot Number 160760190M , Exp. Date 6/15/2016 ; Service Code 2K8243 , Lot Number 160810280M , Exp. Date 6/20/2016 ; Service Code 2K8243 , Lot Number 160820234M , Exp. Date 6/21/2016 ; Service Code 2K8243 , Lot Number 160830120M , Exp. Date 6/21/2016 ; Service Code 2K8243 , Lot Number 160870168M , Exp. Date 6/26/2016 ; Service Code 2K8243 , Lot Number 160900173M , Exp. Date 6/29/2016 ; Service Code 2K8243 , Lot Number 160910176M , Exp. Date 6/30/2016 ; Service Code 2K8243 , Lot Number 160940041M , Exp. Date 7/2/2016 ; Service Code 2K8243 , Lot Number 161080168M , Exp. Date 7/17/2016 ; Service Code 2K9120 , Lot Number 160380034C , Exp. Date 5/8/2016 ; Service Code 2K9120 , Lot Number 160380105M , Exp. Date 5/8/2016 ; Service Code 2K9120 , Lot Number 160420030C , Exp. Date 5/12/2016 ; Service Code 2K9120 , Lot Number 160470039C , Exp. Date 5/17/2016 ; Service Code 2K9120 , Lot Number 160540034C , Exp. Date 5/24/2016 ; Service Code 2K9120 , Lot Number 160550029C , Exp. Date 5/25/2016 ; Service Code 2K9120 , Lot Number 160590078M , Exp. Date 5/29/2016 ; Service Code 2K9120 , Lot Number 160600067M , Exp. Date 5/29/2016 ; Service Code 2K9120 , Lot Number 160670187M , Exp. Date 6/6/2016 ; Service Code 2K9120 , Lot Number 160730076M , Exp. Date 6/11/2016 ; Service Code 2K9120 , Lot Number 160750233M , Exp. Date 6/14/2016 ; Service Code 2K9120 , Lot Number 160770001M , Exp. Date 6/15/2016 ; Service Code 2K9120 , Lot Number 160770049M , Exp. Date 6/15/2016 ; Service Code 2K9120 , Lot Number 160810056M , Exp. Date 6/19/2016 ; Service Code 2K9120 , Lot Number 160870069M , Exp. Date 6/26/2016 ; Service Code 2K9120 , Lot Number 160910184M , Exp. Date 6/30/2016 ; Service Code 2K9120 , Lot Number 160940154M , Exp. Date 7/3/2016 ; Service Code 2K9120 , Lot Number 160960190M , Exp. Date 7/5/2016 ; Service Code 2K9120 , Lot Number 161080156M , Exp. Date 7/17/2016 ; Service Code 2N1120 , Lot Number 160960241M , Exp. Date 7/5/2016 ; Service Code 2N9619 , Lot Number 160950229M , Exp. Date 7/4/2016 ; Service Code 2R3317-5 , Lot Number 160420122M , Exp. Date 5/12/2016 ; Service Code 2R3317-5 , Lot Number 160550206M , Exp. Date 5/24/2016 ; Service Code 2R3317-5 , Lot Number 160590164M , Exp. Date 5/29/2016 ; Service Code 2R3317-5 , Lot Number 160660159M , Exp. Date 6/5/2016 ; Service Code 2R3317-5 , Lot Number 160690151M , Exp. Date 6/7/2016 ; Service Code 2R3317-5 , Lot Number 160740252M , Exp. Date 6/13/2016 ; Service Code 2R3317-5 , Lot Number 160750181M , Exp. Date 6/14/2016 ; Service Code 2R3317-5 , Lot Number 160810298M , Exp. Date 6/20/2016 ; Service Code 2R3317-5 , Lot Number 160830222M , Exp. Date 6/22/2016 ; Service Code 2R3317-5 , Lot Number 160940150M , Exp. Date 7/3/2016 ; Service Code 2R3317-5 , Lot Number 161080209M , Exp. Date 7/17/2016 ; Service Code 3317NO , Lot Number 160380157M , Exp. Date 5/8/2016 ; Service Code 3317NO , Lot Number 160420173M , Exp. Date 5/11/2016 ; Service Code 3317NO , Lot Number 160540140M , Exp. Date 5/24/2016 ; Service Code 3317NO , Lot Number 160600185M , Exp. Date 5/30/2016 ; Service Code 3317NO , Lot Number 160630204M , Exp. Date 6/2/2016 ; Service Code 3317NO , Lot Number 160660172M , Exp. Date 6/5/2016 ; Service Code 3317NO , Lot Number 160700219M , Exp. Date 6/9/2016 ; Service Code 3317NO , Lot Number 160770174M , Exp. Date 6/16/2016 ; Service Code 3317NO , Lot Number 160840205M , Exp. Date 6/23/2016 ; Service Code 3317NO , Lot Number 160910210M , Exp. Date 6/30/2016 ; Service Code 3317NO , Lot Number 161080215M , Exp. Date 7/17/2016 ;
Pharmedium Services, LLC is recalling 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120 , NDC 61553 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