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 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6733, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-20
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 2T6733, Lot Number 160560088M, Exp. Date 5/25/2016, Service Code 2T6733, Lot Number 160590097M, Exp. Date 5/28/2016, Service Code 2T6733, Lot Number 160610032M, Exp. Date 5/31/2016, Service Code 2T6733, Lot Number 160630191M, Exp. Date 6/2/2016, Service Code 2T6733, Lot Number 160740251M, Exp. Date 6/13/2016, Service Code 2T6733, Lot Number 160890051M, Exp. Date 6/27/2016, Service Code 2T6733, Lot Number 160910161M, Exp. Date 6/29/2016, Service Code 2K8478, Lot Number 160380039M, Exp. Date 5/8/2016, Service Code 2K8478, Lot Number 160410139M, Exp. Date 5/11/2016, Service Code 2K8478, Lot Number 160450247M, Exp. Date 5/15/2016, Service Code 2K8478, Lot Number 160540145M, Exp. Date 5/24/2016, Service Code 2K8478, Lot Number 160610157M, Exp. Date 5/31/2016, Service Code 2K8478, Lot Number 160660142M, Exp. Date 6/5/2016, Service Code 2K8478, Lot Number 160730262M, Exp. Date 6/12/2016, Service Code 2K8478, Lot Number 160770247M, Exp. Date 6/16/2016, Service Code 2K8478, Lot Number 160810195M, Exp. Date 6/20/2016, Service Code 2K8478, Lot Number 160890161M, Exp. Date 6/28/2016, Service Code 2K8478, Lot Number 160910234M, Exp. Date 6/30/2016, Service Code 2K8478, Lot Number 160940235M, Exp. Date 7/3/2016, Service Code 2T8478, Lot Number 160910132M, Exp. Date 5/7/2016, Service Code 2T8478, Lot Number 160940032C, Exp. Date 5/10/2016
Products Sold
Service Code 2T6733 , Lot Number 160560088M , Exp. Date 5/25/2016 ; Service Code 2T6733 , Lot Number 160590097M , Exp. Date 5/28/2016 ; Service Code 2T6733 , Lot Number 160610032M , Exp. Date 5/31/2016 ; Service Code 2T6733 , Lot Number 160630191M , Exp. Date 6/2/2016 ; Service Code 2T6733 , Lot Number 160740251M , Exp. Date 6/13/2016 ; Service Code 2T6733 , Lot Number 160890051M , Exp. Date 6/27/2016 ; Service Code 2T6733 , Lot Number 160910161M , Exp. Date 6/29/2016 ; Service Code 2K8478 , Lot Number 160380039M , Exp. Date 5/8/2016 ; Service Code 2K8478 , Lot Number 160410139M , Exp. Date 5/11/2016 ; Service Code 2K8478 , Lot Number 160450247M , Exp. Date 5/15/2016 ; Service Code 2K8478 , Lot Number 160540145M , Exp. Date 5/24/2016 ; Service Code 2K8478 , Lot Number 160610157M , Exp. Date 5/31/2016 ; Service Code 2K8478 , Lot Number 160660142M , Exp. Date 6/5/2016 ; Service Code 2K8478 , Lot Number 160730262M , Exp. Date 6/12/2016 ; Service Code 2K8478 , Lot Number 160770247M , Exp. Date 6/16/2016 ; Service Code 2K8478 , Lot Number 160810195M , Exp. Date 6/20/2016 ; Service Code 2K8478 , Lot Number 160890161M , Exp. Date 6/28/2016 ; Service Code 2K8478 , Lot Number 160910234M , Exp. Date 6/30/2016 ; Service Code 2K8478 , Lot Number 160940235M , Exp. Date 7/3/2016 ; Service Code 2T8478 , Lot Number 160910132M , Exp. Date 5/7/2016 ; Service Code 2T8478 , Lot Number 160940032C , Exp. Date 5/10/2016 ;
Pharmedium Services, LLC is recalling 10 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