Fentanyl Citrate 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
3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8837 (NDC 61553-837-48), Service Code 2K8906 (NDC 61553-906-48), Service Code 2K8963 (NDC 61553-963-48), Service Code 2K8976 (NDC 61553-976-48), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Service Code 3V8708, Lot Number 160410168M, Exp. Date 5/11/2016, Service Code 3V8708, Lot Number 160600286M, Exp. Date 5/30/2016, Service Code 3V8708, Lot Number 160810284M, Exp. Date 6/20/2016, Service Code 3V8708, Lot Number 160820091M, Exp. Date 6/20/2016, Service Code 2H8285, Lot Number 160470170M, Exp. Date 5/13/2016, Service Code 2H8285, Lot Number 160530182M, Exp. Date 5/19/2016, Service Code 2H8285, Lot Number 160600296M, Exp. Date 5/26/2016, Service Code 2H8285, Lot Number 160670185M, Exp. Date 6/2/2016, Service Code 2H8285, Lot Number 160740253M, Exp. Date 6/9/2016, Service Code 2H8285, Lot Number 160820206M, Exp. Date 6/17/2016, Service Code 2H8285, Lot Number 160880254M, Exp. Date 6/23/2016, Service Code 2H8285, Lot Number 160910152M, Exp. Date 6/26/2016, Service Code 2K8237, Lot Number 160400261M, Exp. Date 5/10/2016, Service Code 2K8237, Lot Number 160450263M, Exp. Date 5/15/2016, Service Code 2K8237, Lot Number 160540239M, Exp. Date 5/24/2016, Service Code 2K8237, Lot Number 160620203M, Exp. Date 6/1/2016, Service Code 2K8237, Lot Number 160700152M, Exp. Date 6/9/2016, Service Code 2K8237, Lot Number 160730269M, Exp. Date 6/12/2016, Service Code 2K8237, Lot Number 160760207M, Exp. Date 6/15/2016, Service Code 2K8237, Lot Number 160810315M, Exp. Date 6/20/2016, Service Code 2K8237, Lot Number 160870248M, Exp. Date 6/26/2016, Service Code 2K8237, Lot Number 160940250M, Exp. Date 7/3/2016, Service Code 2K8237, Lot Number 160970220M, Exp. Date 7/6/2016, Service Code 2K8643, Lot Number 160420245M, Exp. Date 5/12/2016, Service Code 2K8643, Lot Number 160470238M, Exp. Date 5/17/2016, Service Code 2K8643, Lot Number 160480261M, Exp. Date 5/18/2016, Service Code 2K8643, Lot Number 160600351M, Exp. Date 5/30/2016, Service Code 2K8643, Lot Number 160700177M, Exp. Date 6/9/2016, Service Code 2K8643, Lot Number 160770260M, Exp. Date 6/16/2016, Service Code 2K8643, Lot Number 160870191M, Exp. Date 6/26/2016, Service Code 2K8643, Lot Number 160910247M, Exp. Date 6/30/2016, Service Code 2K8643, Lot Number 161080279M, Exp. Date 7/17/2016, Service Code 2K8837, Lot Number 160460262M, Exp. Date 5/7/2016, Service Code 2K8837, Lot Number 160530235M, Exp. Date 5/14/2016, Service Code 2K8837, Lot Number 160600335M, Exp. Date 5/21/2016, Service Code 2K8837, Lot Number 160630109M, Exp. Date 5/24/2016, Service Code 2K8837, Lot Number 160740138M, Exp. Date 6/4/2016, Service Code 2K8837, Lot Number 160770249M, Exp. Date 6/7/2016, Service Code 2K8837, Lot Number 160870243M, Exp. Date 6/17/2016, Service Code 2K8837, Lot Number 160880159M, Exp. Date 6/18/2016, Service Code 2K8837, Lot Number 160900184M, Exp. Date 6/20/2016, Service Code 2K8837, Lot Number 160960129M, Exp. Date 6/26/2016, Service Code 2K8906, Lot Number 160480019M, Exp. Date 5/9/2016, Service Code 2K8906, Lot Number 160540174M, Exp. Date 5/15/2016, Service Code 2K8906, Lot Number 160610163M, Exp. Date 5/22/2016, Service Code 2K8906, Lot Number 160700148M, Exp. Date 5/31/2016, Service Code 2K8906, Lot Number 160750221M, Exp. Date 6/5/2016, Service Code 2K8906, Lot Number 160770136M, Exp. Date 6/7/2016, Service Code 2K8906, Lot Number 160820127M, Exp. Date 6/12/2016, Service Code 2K8906, Lot Number 160890210M, Exp. Date 6/19/2016, Service Code 2K8906, Lot Number 160960171M, Exp. Date 6/26/2016, Service Code 2K8963, Lot Number 160550244M, Exp. Date 5/16/2016, Service Code 2K8963, Lot Number 160560180M, Exp. Date 5/17/2016, Service Code 2K8963, Lot Number 160670202M, Exp. Date 5/28/2016, Service Code 2K8963, Lot Number 160750055C, Exp. Date 6/5/2016, Service Code 2K8963, Lot Number 160760031C, Exp. Date 6/6/2016, Service Code 2K8963, Lot Number 160810065C, Exp. Date 6/11/2016, Service Code 2K8963, Lot Number 160820057C, Exp. Date 6/12/2016, Service Code 2K8963, Lot Number 160890042C, Exp. Date 6/19/2016, Service Code 2K8963, Lot Number 160950052C, Exp. Date 6/25/2016, Service Code 2K8963, Lot Number 160950187M, Exp. Date 6/25/2016, Service Code 2K8976, Lot Number 160470034C, Exp. Date 5/8/2016, Service Code 2K8976, Lot Number 160840015C, Exp. Date 6/14/2016, Service Code 2K8976, Lot Number 160880064C, Exp. Date 6/18/2016, Service Code 2K9285, Lot Number 160450032C, Exp. Date 5/9/2016, Service Code 2K9285, Lot Number 160520065C, Exp. Date 5/16/2016, Service Code 2K9285, Lot Number 160630020C, Exp. Date 5/27/2016, Service Code 2K9285, Lot Number 160690030C, Exp. Date 6/2/2016, Service Code 2K9285, Lot Number 160770036C, Exp. Date 6/10/2016, Service Code 2K9285, Lot Number 160840031C, Exp. Date 6/17/2016, Service Code 2K9285, Lot Number 160880075C, Exp. Date 6/21/2016
Products Sold
Service Code 3V8708 , Lot Number 160410168M , Exp. Date 5/11/2016 ; Service Code 3V8708 , Lot Number 160600286M , Exp. Date 5/30/2016 ; Service Code 3V8708 , Lot Number 160810284M , Exp. Date 6/20/2016 ; Service Code 3V8708 , Lot Number 160820091M , Exp. Date 6/20/2016 ; Service Code 2H8285 , Lot Number 160470170M , Exp. Date 5/13/2016 ; Service Code 2H8285 , Lot Number 160530182M , Exp. Date 5/19/2016 ; Service Code 2H8285 , Lot Number 160600296M , Exp. Date 5/26/2016 ; Service Code 2H8285 , Lot Number 160670185M , Exp. Date 6/2/2016 ; Service Code 2H8285 , Lot Number 160740253M , Exp. Date 6/9/2016 ; Service Code 2H8285 , Lot Number 160820206M , Exp. Date 6/17/2016 ; Service Code 2H8285 , Lot Number 160880254M , Exp. Date 6/23/2016 ; Service Code 2H8285 , Lot Number 160910152M , Exp. Date 6/26/2016 ; Service Code 2K8237 , Lot Number 160400261M , Exp. Date 5/10/2016 ; Service Code 2K8237 , Lot Number 160450263M , Exp. Date 5/15/2016 ; Service Code 2K8237 , Lot Number 160540239M , Exp. Date 5/24/2016 ; Service Code 2K8237 , Lot Number 160620203M , Exp. Date 6/1/2016 ; Service Code 2K8237 , Lot Number 160700152M , Exp. Date 6/9/2016 ; Service Code 2K8237 , Lot Number 160730269M , Exp. Date 6/12/2016 ; Service Code 2K8237 , Lot Number 160760207M , Exp. Date 6/15/2016 ; Service Code 2K8237 , Lot Number 160810315M , Exp. Date 6/20/2016 ; Service Code 2K8237 , Lot Number 160870248M , Exp. Date 6/26/2016 ; Service Code 2K8237 , Lot Number 160940250M , Exp. Date 7/3/2016 ; Service Code 2K8237 , Lot Number 160970220M , Exp. Date 7/6/2016 ; Service Code 2K8643 , Lot Number 160420245M , Exp. Date 5/12/2016 ; Service Code 2K8643 , Lot Number 160470238M , Exp. Date 5/17/2016 ; Service Code 2K8643 , Lot Number 160480261M , Exp. Date 5/18/2016 ; Service Code 2K8643 , Lot Number 160600351M , Exp. Date 5/30/2016 ; Service Code 2K8643 , Lot Number 160700177M , Exp. Date 6/9/2016 ; Service Code 2K8643 , Lot Number 160770260M , Exp. Date 6/16/2016 ; Service Code 2K8643 , Lot Number 160870191M , Exp. Date 6/26/2016 ; Service Code 2K8643 , Lot Number 160910247M , Exp. Date 6/30/2016 ; Service Code 2K8643 , Lot Number 161080279M , Exp. Date 7/17/2016 ; Service Code 2K8837 , Lot Number 160460262M , Exp. Date 5/7/2016 ; Service Code 2K8837 , Lot Number 160530235M , Exp. Date 5/14/2016 ; Service Code 2K8837 , Lot Number 160600335M , Exp. Date 5/21/2016 ; Service Code 2K8837 , Lot Number 160630109M , Exp. Date 5/24/2016 ; Service Code 2K8837 , Lot Number 160740138M , Exp. Date 6/4/2016 ; Service Code 2K8837 , Lot Number 160770249M , Exp. Date 6/7/2016 ; Service Code 2K8837 , Lot Number 160870243M , Exp. Date 6/17/2016 ; Service Code 2K8837 , Lot Number 160880159M , Exp. Date 6/18/2016 ; Service Code 2K8837 , Lot Number 160900184M , Exp. Date 6/20/2016 ; Service Code 2K8837 , Lot Number 160960129M , Exp. Date 6/26/2016 ; Service Code 2K8906 , Lot Number 160480019M , Exp. Date 5/9/2016 ; Service Code 2K8906 , Lot Number 160540174M , Exp. Date 5/15/2016 ; Service Code 2K8906 , Lot Number 160610163M , Exp. Date 5/22/2016 ; Service Code 2K8906 , Lot Number 160700148M , Exp. Date 5/31/2016 ; Service Code 2K8906 , Lot Number 160750221M , Exp. Date 6/5/2016 ; Service Code 2K8906 , Lot Number 160770136M , Exp. Date 6/7/2016 ; Service Code 2K8906 , Lot Number 160820127M , Exp. Date 6/12/2016 ; Service Code 2K8906 , Lot Number 160890210M , Exp. Date 6/19/2016 ; Service Code 2K8906 , Lot Number 160960171M , Exp. Date 6/26/2016 ; Service Code 2K8963 , Lot Number 160550244M , Exp. Date 5/16/2016 ; Service Code 2K8963 , Lot Number 160560180M , Exp. Date 5/17/2016 ; Service Code 2K8963 , Lot Number 160670202M , Exp. Date 5/28/2016 ; Service Code 2K8963 , Lot Number 160750055C , Exp. Date 6/5/2016 ; Service Code 2K8963 , Lot Number 160760031C , Exp. Date 6/6/2016 ; Service Code 2K8963 , Lot Number 160810065C , Exp. Date 6/11/2016 ; Service Code 2K8963 , Lot Number 160820057C , Exp. Date 6/12/2016 ; Service Code 2K8963 , Lot Number 160890042C , Exp. Date 6/19/2016 ; Service Code 2K8963 , Lot Number 160950052C , Exp. Date 6/25/2016 ; Service Code 2K8963 , Lot Number 160950187M , Exp. Date 6/25/2016 ; Service Code 2K8976 , Lot Number 160470034C , Exp. Date 5/8/2016 ; Service Code 2K8976 , Lot Number 160840015C , Exp. Date 6/14/2016 ; Service Code 2K8976 , Lot Number 160880064C , Exp. Date 6/18/2016 ; Service Code 2K9285 , Lot Number 160450032C , Exp. Date 5/9/2016 ; Service Code 2K9285 , Lot Number 160520065C , Exp. Date 5/16/2016 ; Service Code 2K9285 , Lot Number 160630020C , Exp. Date 5/27/2016 ; Service Code 2K9285 , Lot Number 160690030C , Exp. Date 6/2/2016 ; Service Code 2K9285 , Lot Number 160770036C , Exp. Date 6/10/2016 ; Service Code 2K9285 , Lot Number 160840031C , Exp. Date 6/17/2016 ; Service Code 2K9285 , Lot Number 160880075C , Exp. Date 6/21/2016 ;
Pharmedium Services, LLC is recalling 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 10 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