Hydromorphone Bupivacaine 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
8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9310, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-310-50
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Lot Number 160390094M, Exp. Date 5/9/2016, Lot Number 160450111M, Exp. Date 5/15/2016, Lot Number 160520101M, Exp. Date 5/22/2016, Lot Number 160550109M, Exp. Date 5/25/2016, Lot Number 160610124M, Exp. Date 5/31/2016, Lot Number 160620115M, Exp. Date 6/1/2016, Lot Number 160670036M, Exp. Date 6/5/2016, Lot Number 160680038M, Exp. Date 6/7/2016, Lot Number 160690110M, Exp. Date 6/7/2016, Lot Number 160740117M, Exp. Date 6/12/2016, Lot Number 160760109M, Exp. Date 6/15/2016, Lot Number 160820103M, Exp. Date 6/21/2016, Lot Number 160830107M, Exp. Date 6/22/2016, Lot Number 160900032M, Exp. Date 6/29/2016, Lot Number 160970021M, Exp. Date 7/6/2016
Products Sold
Lot Number 160390094M , Exp. Date 5/9/2016 ; Lot Number 160450111M , Exp. Date 5/15/2016 ; Lot Number 160520101M , Exp. Date 5/22/2016 ; Lot Number 160550109M , Exp. Date 5/25/2016 ; Lot Number 160610124M , Exp. Date 5/31/2016 ; Lot Number 160620115M , Exp. Date 6/1/2016 ; Lot Number 160670036M , Exp. Date 6/5/2016 ; Lot Number 160680038M , Exp. Date 6/7/2016 ; Lot Number 160690110M , Exp. Date 6/7/2016 ; Lot Number 160740117M , Exp. Date 6/12/2016 ; Lot Number 160760109M , Exp. Date 6/15/2016 ; Lot Number 160820103M , Exp. Date 6/21/2016 ; Lot Number 160830107M , Exp. Date 6/22/2016 ; Lot Number 160900032M , Exp. Date 6/29/2016 ; Lot Number 160970021M , Exp. Date 7/6/2016 ;
Pharmedium Services, LLC is recalling 8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 25 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