Bupivacaine HCl Solution (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
0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2N1488, Lot Number 160520176M, Exp. Date 5/22/2016, Service Code 2N1488, Lot Number 160600059M, Exp. Date 5/30/2016, Service Code 2N1488, Lot Number 160970115M, Exp. Date 7/5/2016, Service Code 2N1489, Lot Number 160490027C, Exp. Date 5/19/2016, Service Code 2N1489, Lot Number 160560032C, Exp. Date 5/26/2016, Service Code 2N1489, Lot Number 160620024C, Exp. Date 6/1/2016, Service Code 2N1489, Lot Number 160630029C, Exp. Date 6/2/2016, Service Code 2N1489, Lot Number 160670059C, Exp. Date 6/6/2016, Service Code 2N1489, Lot Number 160700047C, Exp. Date 6/9/2016, Service Code 2N1489, Lot Number 160730025C, Exp. Date 6/12/2016, Service Code 2N1489, Lot Number 160810057C, Exp. Date 6/20/2016, Service Code 2R3332-5, Lot Number 160420156M, Exp. Date 5/11/2016, Service Code 2R3332-5, Lot Number 160470152M, Exp. Date 5/16/2016, Service Code 2R3332-5, Lot Number 160620035M, Exp. Date 5/31/2016, Service Code 2R3332-5, Lot Number 160770159M, Exp. Date 6/16/2016, Service Code 2R3332-5, Lot Number 160830044M, Exp. Date 6/21/2016, Service Code 2R3332-5, Lot Number 160970032M, Exp. Date 7/5/2016, Service Code 3332NO, Lot Number 160380115M, Exp. Date 5/7/2016, Service Code 3332NO, Lot Number 160420112M, Exp. Date 5/11/2016, Service Code 3332NO, Lot Number 160540138M, Exp. Date 5/24/2016, Service Code 3332NO, Lot Number 160660215M, Exp. Date 6/5/2016, Service Code 3332NO, Lot Number 160690125M, Exp. Date 6/7/2016, Service Code 3332NO, Lot Number 160750228M, Exp. Date 6/14/2016, Service Code 3332NO, Lot Number 160900145M, Exp. Date 6/28/2016, Service Code 3332NO, Lot Number 160950153M, Exp. Date 7/4/2016
Products Sold
Service Code 2N1488 , Lot Number 160520176M , Exp. Date 5/22/2016 ; Service Code 2N1488 , Lot Number 160600059M , Exp. Date 5/30/2016 ; Service Code 2N1488 , Lot Number 160970115M , Exp. Date 7/5/2016 ; Service Code 2N1489 , Lot Number 160490027C , Exp. Date 5/19/2016 ; Service Code 2N1489 , Lot Number 160560032C , Exp. Date 5/26/2016 ; Service Code 2N1489 , Lot Number 160620024C , Exp. Date 6/1/2016 ; Service Code 2N1489 , Lot Number 160630029C , Exp. Date 6/2/2016 ; Service Code 2N1489 , Lot Number 160670059C , Exp. Date 6/6/2016 ; Service Code 2N1489 , Lot Number 160700047C , Exp. Date 6/9/2016 ; Service Code 2N1489 , Lot Number 160730025C , Exp. Date 6/12/2016 ; Service Code 2N1489 , Lot Number 160810057C , Exp. Date 6/20/2016 ; Service Code 2R3332-5 , Lot Number 160420156M , Exp. Date 5/11/2016 ; Service Code 2R3332-5 , Lot Number 160470152M , Exp. Date 5/16/2016 ; Service Code 2R3332-5 , Lot Number 160620035M , Exp. Date 5/31/2016 ; Service Code 2R3332-5 , Lot Number 160770159M , Exp. Date 6/16/2016 ; Service Code 2R3332-5 , Lot Number 160830044M , Exp. Date 6/21/2016 ; Service Code 2R3332-5 , Lot Number 160970032M , Exp. Date 7/5/2016 ; Service Code 3332NO , Lot Number 160380115M , Exp. Date 5/7/2016 ; Service Code 3332NO , Lot Number 160420112M , Exp. Date 5/11/2016 ; Service Code 3332NO , Lot Number 160540138M , Exp. Date 5/24/2016 ; Service Code 3332NO , Lot Number 160660215M , Exp. Date 6/5/2016 ; Service Code 3332NO , Lot Number 160690125M , Exp. Date 6/7/2016 ; Service Code 3332NO , Lot Number 160750228M , Exp. Date 6/14/2016 ; Service Code 3332NO , Lot Number 160900145M , Exp. Date 6/28/2016 ; Service Code 3332NO , Lot Number 160950153M , Exp. Date 7/4/2016 ;
Pharmedium Services, LLC is recalling 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 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