Bupivacaine Sodium Chloride (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
0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (NDC 61553-463-47), 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8931(NDC 61553-931-02), 400 ml in 500 mL Baxter Intravia Bag, Service Code 2N1119, (NDC 61553-119-84), Rx
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2K8119, Lot Number 160480208M, Exp. Date 5/18/2016, Service Code 2K8119, Lot Number 160490134M, Exp. Date 5/19/2016, Service Code 2K8119, Lot Number 160520129M, Exp. Date 5/22/2016, Service Code 2K8119, Lot Number 160530167M, Exp. Date 5/23/2016, Service Code 2K8119, Lot Number 160700126M, Exp. Date 6/8/2016, Service Code 2K8119, Lot Number 160740148M, Exp. Date 6/13/2016, Service Code 2K8119, Lot Number 160750046M, Exp. Date 6/13/2016, Service Code 2K8119, Lot Number 160820124M, Exp. Date 6/21/2016, Service Code 2K8171, Lot Number 160880264M, Exp. Date 6/27/2016, Service Code 2K8217, Lot Number 160380114M, Exp. Date 5/8/2016, Service Code 2K8217, Lot Number 160410116M, Exp. Date 5/11/2016, Service Code 2K8217, Lot Number 160480128M, Exp. Date 5/18/2016, Service Code 2K8217, Lot Number 160540123M, Exp. Date 5/23/2016, Service Code 2K8217, Lot Number 160600196M, Exp. Date 5/30/2016, Service Code 2K8217, Lot Number 160730054M, Exp. Date 6/12/2016, Service Code 2K8217, Lot Number 160740245M, Exp. Date 6/13/2016, Service Code 2K8217, Lot Number 160750048M, Exp. Date 6/13/2016, Service Code 2K8217, Lot Number 160840149M, Exp. Date 6/23/2016, Service Code 2K8217, Lot Number 160900131M, Exp. Date 6/29/2016, Service Code 2K8217, Lot Number 160960139M, Exp. Date 7/5/2016, Service Code 2K8463, Lot Number 160400227M, Exp. Date 5/10/2016, Service Code 2K8463, Lot Number 160630030M, Exp. Date 6/1/2016, Service Code 2K8463, Lot Number 160890243M, Exp. Date 6/28/2016, Service Code 2K8463, Lot Number 160970195M, Exp. Date 7/6/2016, Service Code 2K8931, Lot Number 160970018C, Exp. Date 5/7/2016, Service Code 2N1119, Lot Number 160490041C, Exp. Date 5/19/2016
Products Sold
Service Code 2K8119 , Lot Number 160480208M , Exp. Date 5/18/2016 ; Service Code 2K8119 , Lot Number 160490134M , Exp. Date 5/19/2016 ; Service Code 2K8119 , Lot Number 160520129M , Exp. Date 5/22/2016 ; Service Code 2K8119 , Lot Number 160530167M , Exp. Date 5/23/2016 ; Service Code 2K8119 , Lot Number 160700126M , Exp. Date 6/8/2016 ; Service Code 2K8119 , Lot Number 160740148M , Exp. Date 6/13/2016 ; Service Code 2K8119 , Lot Number 160750046M , Exp. Date 6/13/2016 ; Service Code 2K8119 , Lot Number 160820124M , Exp. Date 6/21/2016 ; Service Code 2K8171 , Lot Number 160880264M , Exp. Date 6/27/2016 ; Service Code 2K8217 , Lot Number 160380114M , Exp. Date 5/8/2016 ; Service Code 2K8217 , Lot Number 160410116M , Exp. Date 5/11/2016 ; Service Code 2K8217 , Lot Number 160480128M , Exp. Date 5/18/2016 ; Service Code 2K8217 , Lot Number 160540123M , Exp. Date 5/23/2016 ; Service Code 2K8217 , Lot Number 160600196M , Exp. Date 5/30/2016 ; Service Code 2K8217 , Lot Number 160730054M , Exp. Date 6/12/2016 ; Service Code 2K8217 , Lot Number 160740245M , Exp. Date 6/13/2016 ; Service Code 2K8217 , Lot Number 160750048M , Exp. Date 6/13/2016 ; Service Code 2K8217 , Lot Number 160840149M , Exp. Date 6/23/2016 ; Service Code 2K8217 , Lot Number 160900131M , Exp. Date 6/29/2016 ; Service Code 2K8217 , Lot Number 160960139M , Exp. Date 7/5/2016 ; Service Code 2K8463 , Lot Number 160400227M , Exp. Date 5/10/2016 ; Service Code 2K8463 , Lot Number 160630030M , Exp. Date 6/1/2016 ; Service Code 2K8463 , Lot Number 160890243M , Exp. Date 6/28/2016 ; Service Code 2K8463 , Lot Number 160970195M , Exp. Date 7/6/2016 ; Service Code 2K8931 , Lot Number 160970018C , Exp. Date 5/7/2016 ; Service Code 2N1119 , Lot Number 160490041C , Exp. Date 5/19/2016 ;
Pharmedium Services, LLC is recalling 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia B 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