HYDROmorphone HCl Bupivacaine (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
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8483, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-483-61
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Lot Number 160380152M, Exp. Date 5/8/2016, Lot Number 160400233M, Exp. Date 5/10/2016, Lot Number 160540186M, Exp. Date 5/24/2016, Lot Number 160660046M, Exp. Date 6/4/2016, Lot Number 160730154M, Exp. Date 6/12/2016, Lot Number 160750176M, Exp. Date 6/14/2016, Lot Number 160760046M, Exp. Date 6/14/2016, Lot Number 160800066M, Exp. Date 6/18/2016, Lot Number 160820111M, Exp. Date 6/20/2016, Lot Number 160960039M, Exp. Date 7/4/2016
Products Sold
Lot Number 160380152M , Exp. Date 5/8/2016 ; Lot Number 160400233M , Exp. Date 5/10/2016 ; Lot Number 160540186M , Exp. Date 5/24/2016 ; Lot Number 160660046M , Exp. Date 6/4/2016 ; Lot Number 160730154M , Exp. Date 6/12/2016 ; Lot Number 160750176M , Exp. Date 6/14/2016 ; Lot Number 160760046M , Exp. Date 6/14/2016 ; Lot Number 160800066M , Exp. Date 6/18/2016 ; Lot Number 160820111M , Exp. Date 6/20/2016 ; Lot Number 160960039M , Exp. Date 7/4/2016 ;
Pharmedium Services, LLC is recalling 5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 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