HYDROmorphone HCl and Bupivacaine HCl (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
10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette (stop free-flow protection), Service Code 2K8909, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-909-02 ,
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2H8481, Lot Number 160460180M, Exp. Date 5/16/2016, Service Code 2H8481, Lot Number 160540181M, Exp. Date 5/24/2016, Service Code 2H8481, Lot Number 160830170M, Exp. Date 6/22/2016, Service Code 2K8481, Lot Number 160380110M, Exp. Date 5/8/2016, Service Code 2K8481, Lot Number 160390206M, Exp. Date 5/9/2016, Service Code 2K8481, Lot Number 160400241M, Exp. Date 5/10/2016, Service Code 2K8481, Lot Number 160410170M, Exp. Date 5/11/2016, Service Code 2K8481, Lot Number 160450130M, Exp. Date 5/15/2016, Service Code 2K8481, Lot Number 160480181M, Exp. Date 5/18/2016, Service Code 2K8481, Lot Number 160520033M, Exp. Date 5/22/2016, Service Code 2K8481, Lot Number 160530127M, Exp. Date 5/23/2016, Service Code 2K8481, Lot Number 160540137M, Exp. Date 5/24/2016, Service Code 2K8481, Lot Number 160560212M, Exp. Date 5/26/2016, Service Code 2K8481, Lot Number 160600294M, Exp. Date 5/30/2016, Service Code 2K8481, Lot Number 160610237M, Exp. Date 5/31/2016, Service Code 2K8481, Lot Number 160630118M, Exp. Date 6/2/2016, Service Code 2K8481, Lot Number 160660175M, Exp. Date 6/5/2016, Service Code 2K8481, Lot Number 160670245M, Exp. Date 6/6/2016, Service Code 2K8481, Lot Number 160730063M, Exp. Date 6/12/2016, Service Code 2K8481, Lot Number 160770227M, Exp. Date 6/16/2016, Service Code 2K8481, Lot Number 160840171M, Exp. Date 6/23/2016, Service Code 2K8481, Lot Number 160870146M, Exp. Date 6/26/2016, Service Code 2K8481, Lot Number 160910219M, Exp. Date 6/30/2016, Service Code 2K8481, Lot Number 160940163M, Exp. Date 7/3/2016, Service Code 2K8481, Lot Number 160970137M, Exp. Date 7/6/2016, Service Code 2K8481, Lot Number 161080124M, Exp. Date 7/17/2016, Service Code 2K8909, Lot Number 160910236M, Exp. Date 5/7/2016, Service Code 2K8909, Lot Number 160950070C, Exp. Date 5/11/2016, Service Code 2K8909, Lot Number 161080282M, Exp. Date 5/24/2016, Service Code 2K8911, Lot Number 160970035M, Exp. Date 5/6/2016, Service Code 2T6481, Lot Number 160590144M, Exp. Date 5/29/2016, Service Code 2T6481, Lot Number 160610031M, Exp. Date 5/31/2016
Products Sold
Service Code 2H8481 , Lot Number 160460180M , Exp. Date 5/16/2016 ; Service Code 2H8481 , Lot Number 160540181M , Exp. Date 5/24/2016 ; Service Code 2H8481 , Lot Number 160830170M , Exp. Date 6/22/2016 ; Service Code 2K8481 , Lot Number 160380110M , Exp. Date 5/8/2016 ; Service Code 2K8481 , Lot Number 160390206M , Exp. Date 5/9/2016 ; Service Code 2K8481 , Lot Number 160400241M , Exp. Date 5/10/2016 ; Service Code 2K8481 , Lot Number 160410170M , Exp. Date 5/11/2016 ; Service Code 2K8481 , Lot Number 160450130M , Exp. Date 5/15/2016 ; Service Code 2K8481 , Lot Number 160480181M , Exp. Date 5/18/2016 ; Service Code 2K8481 , Lot Number 160520033M , Exp. Date 5/22/2016 ; Service Code 2K8481 , Lot Number 160530127M , Exp. Date 5/23/2016 ; Service Code 2K8481 , Lot Number 160540137M , Exp. Date 5/24/2016 ; Service Code 2K8481 , Lot Number 160560212M , Exp. Date 5/26/2016 ; Service Code 2K8481 , Lot Number 160600294M , Exp. Date 5/30/2016 ; Service Code 2K8481 , Lot Number 160610237M , Exp. Date 5/31/2016 ; Service Code 2K8481 , Lot Number 160630118M , Exp. Date 6/2/2016 ; Service Code 2K8481 , Lot Number 160660175M , Exp. Date 6/5/2016 ; Service Code 2K8481 , Lot Number 160670245M , Exp. Date 6/6/2016 ; Service Code 2K8481 , Lot Number 160730063M , Exp. Date 6/12/2016 ; Service Code 2K8481 , Lot Number 160770227M , Exp. Date 6/16/2016 ; Service Code 2K8481 , Lot Number 160840171M , Exp. Date 6/23/2016 ; Service Code 2K8481 , Lot Number 160870146M , Exp. Date 6/26/2016 ; Service Code 2K8481 , Lot Number 160910219M , Exp. Date 6/30/2016 ; Service Code 2K8481 , Lot Number 160940163M , Exp. Date 7/3/2016 ; Service Code 2K8481 , Lot Number 160970137M , Exp. Date 7/6/2016 ; Service Code 2K8481 , Lot Number 161080124M , Exp. Date 7/17/2016 ; Service Code 2K8909 , Lot Number 160910236M , Exp. Date 5/7/2016 ; Service Code 2K8909 , Lot Number 160950070C , Exp. Date 5/11/2016 ; Service Code 2K8909 , Lot Number 161080282M , Exp. Date 5/24/2016 ; Service Code 2K8911 , Lot Number 160970035M , Exp. Date 5/6/2016 ; Service Code 2T6481 , Lot Number 160590144M , Exp. Date 5/29/2016 ; Service Code 2T6481 , Lot Number 160610031M , Exp. Date 5/31/2016 ;
Pharmedium Services, LLC is recalling 10 mcg/mL HYDROmorphone HCl and 0.1% 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