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
10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8908, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-908-02 ,
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2K8482, Lot Number 160400113M, Exp. Date 5/10/2016, Service Code 2K8482, Lot Number 160460097M, Exp. Date 5/16/2016, Service Code 2K8482, Lot Number 160470229M, Exp. Date 5/17/2016, Service Code 2K8482, Lot Number 160530109M, Exp. Date 5/23/2016, Service Code 2K8482, Lot Number 160630133M, Exp. Date 6/2/2016, Service Code 2K8482, Lot Number 160670166M, Exp. Date 6/6/2016, Service Code 2K8482, Lot Number 160680146M, Exp. Date 6/7/2016, Service Code 2K8482, Lot Number 160750150M, Exp. Date 6/14/2016, Service Code 2K8482, Lot Number 160810139M, Exp. Date 6/20/2016, Service Code 2K8482, Lot Number 160910246M, Exp. Date 6/30/2016, Service Code 2K8482, Lot Number 160960036C, Exp. Date 7/5/2016, Service Code 2K8482, Lot Number 160970147M, Exp. Date 7/6/2016, Service Code 2K8482, Lot Number 161080277M, Exp. Date 7/17/2016, Service Code 2K8908, Lot Number 160940041C, Exp. Date 5/10/2016, Service Code 2K8908, Lot Number 160950030C, Exp. Date 5/11/2016, Service Code 2T6482, Lot Number 160560209M, Exp. Date 5/26/2016, Service Code 2T6482, Lot Number 160590158M, Exp. Date 5/29/2016, Service Code 2T6482, Lot Number 160750214M, Exp. Date 6/14/2016
Products Sold
Service Code 2K8482 , Lot Number 160400113M , Exp. Date 5/10/2016 ; Service Code 2K8482 , Lot Number 160460097M , Exp. Date 5/16/2016 ; Service Code 2K8482 , Lot Number 160470229M , Exp. Date 5/17/2016 ; Service Code 2K8482 , Lot Number 160530109M , Exp. Date 5/23/2016 ; Service Code 2K8482 , Lot Number 160630133M , Exp. Date 6/2/2016 ; Service Code 2K8482 , Lot Number 160670166M , Exp. Date 6/6/2016 ; Service Code 2K8482 , Lot Number 160680146M , Exp. Date 6/7/2016 ; Service Code 2K8482 , Lot Number 160750150M , Exp. Date 6/14/2016 ; Service Code 2K8482 , Lot Number 160810139M , Exp. Date 6/20/2016 ; Service Code 2K8482 , Lot Number 160910246M , Exp. Date 6/30/2016 ; Service Code 2K8482 , Lot Number 160960036C , Exp. Date 7/5/2016 ; Service Code 2K8482 , Lot Number 160970147M , Exp. Date 7/6/2016 ; Service Code 2K8482 , Lot Number 161080277M , Exp. Date 7/17/2016 ; Service Code 2K8908 , Lot Number 160940041C , Exp. Date 5/10/2016 ; Service Code 2K8908 , Lot Number 160950030C , Exp. Date 5/11/2016 ; Service Code 2T6482 , Lot Number 160560209M , Exp. Date 5/26/2016 ; Service Code 2T6482 , Lot Number 160590158M , Exp. Date 5/29/2016 ; Service Code 2T6482 , Lot Number 160750214M , Exp. Date 6/14/2016 ;
Pharmedium Services, LLC is recalling 10 mcg/mL HYDROmorphone HCl and 0.125% 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