4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48

Class I - Dangerous

💊 Drugs Recalled: May 5, 2016 Pharmedium Services Prescription Drugs Nationwide

What Should You Do?

Check if you have this product:
Service Code 2H8267 , Lot Number 160630024M , Exp. Date 5/28/2016 ; Service Code 2K8128 , Lot Number 160490252M , Exp. Date 5/13/2016 ; Service Code 2K8128 , Lot Number 160530274M , Exp. Date 5/17/2016 ; Service Code 2K8128 , Lot Number 160600213M , Exp. Date 5/24/2016 ; Service Code 2K8128 , Lot Number 160660184M , Exp. Date 5/30/2016 ; Service Code 2K8128 , Lot Number 160730236M , Exp. Date 6/6/2016 ; Service Code 2K8128 , Lot Number 160810218M , Exp. Date 6/14/2016 ; Service Code 2K8128 , Lot Number 160820186M , Exp. Date 6/15/2016 ; Service Code 2K8128 , Lot Number 160940172M , Exp. Date 6/27/2016 ; Service Code 2K8267 , Lot Number 160450259M , Exp. Date 5/15/2016 ; Service Code 2K8267 , Lot Number 160540156M , Exp. Date 5/24/2016 ; Service Code 2K8267 , Lot Number 160600323M , Exp. Date 5/30/2016 ; Service Code 2K8267 , Lot Number 160660257M , Exp. Date 6/5/2016 ; Service Code 2K8267 , Lot Number 160730258M , Exp. Date 6/12/2016 ; Service Code 2K8267 , Lot Number 160770130M , Exp. Date 6/16/2016 ; Service Code 2K8267 , Lot Number 160840132M , Exp. Date 6/23/2016 ; Service Code 2K8267 , Lot Number 160900007M , Exp. Date 6/28/2016 ; Service Code 2K8267 , Lot Number 160970143M , Exp. Date 7/6/2016 ; Service Code 2K8267 , Lot Number 161080249M , Exp. Date 7/17/2016 ; Service Code 2K8638 , Lot Number 160410229M , Exp. Date 5/11/2016 ; Service Code 2K8638 , Lot Number 160420200M , Exp. Date 5/12/2016 ; Service Code 2K8638 , Lot Number 160460214M , Exp. Date 5/16/2016 ; Service Code 2K8638 , Lot Number 160480210M , Exp. Date 5/17/2016 ; Service Code 2K8638 , Lot Number 160490254M , Exp. Date 5/19/2016 ; Service Code 2K8638 , Lot Number 160490255M , Exp. Date 5/19/2016 ; Service Code 2K8638 , Lot Number 160520127M , Exp. Date 5/22/2016 ; Service Code 2K8638 , Lot Number 160600310M , Exp. Date 5/30/2016 ; Service Code 2K8638 , Lot Number 160630164M , Exp. Date 6/2/2016 ; Service Code 2K8638 , Lot Number 160670272M , Exp. Date 6/6/2016 ; Service Code 2K8638 , Lot Number 160750259M , Exp. Date 6/14/2016 ; Service Code 2K8638 , Lot Number 160770264M , Exp. Date 6/16/2016 ; Service Code 2K8638 , Lot Number 160840238M , Exp. Date 6/23/2016 ; Service Code 2K8638 , Lot Number 160870197M , Exp. Date 6/26/2016 ; Service Code 2K8638 , Lot Number 160950189M , Exp. Date 7/4/2016 ; Service Code 2K8983 , Lot Number 160530047C , Exp. Date 5/14/2016 ; Service Code 2K8983 , Lot Number 160740088C , Exp. Date 6/4/2016 ; Service Code 2K8983 , Lot Number 160880066C , Exp. Date 6/18/2016 ; Service Code 2K8983 , Lot Number 160970040C , Exp. Date 6/27/2016 ;
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Pharmedium Services, LLC
Reason for Recall:: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48

Product Codes/Lot Numbers:

Service Code 2H8267 , Lot Number 160630024M , Exp. Date 5/28/2016 ; Service Code 2K8128 , Lot Number 160490252M , Exp. Date 5/13/2016 ; Service Code 2K8128 , Lot Number 160530274M , Exp. Date 5/17/2016 ; Service Code 2K8128 , Lot Number 160600213M , Exp. Date 5/24/2016 ; Service Code 2K8128 , Lot Number 160660184M , Exp. Date 5/30/2016 ; Service Code 2K8128 , Lot Number 160730236M , Exp. Date 6/6/2016 ; Service Code 2K8128 , Lot Number 160810218M , Exp. Date 6/14/2016 ; Service Code 2K8128 , Lot Number 160820186M , Exp. Date 6/15/2016 ; Service Code 2K8128 , Lot Number 160940172M , Exp. Date 6/27/2016 ; Service Code 2K8267 , Lot Number 160450259M , Exp. Date 5/15/2016 ; Service Code 2K8267 , Lot Number 160540156M , Exp. Date 5/24/2016 ; Service Code 2K8267 , Lot Number 160600323M , Exp. Date 5/30/2016 ; Service Code 2K8267 , Lot Number 160660257M , Exp. Date 6/5/2016 ; Service Code 2K8267 , Lot Number 160730258M , Exp. Date 6/12/2016 ; Service Code 2K8267 , Lot Number 160770130M , Exp. Date 6/16/2016 ; Service Code 2K8267 , Lot Number 160840132M , Exp. Date 6/23/2016 ; Service Code 2K8267 , Lot Number 160900007M , Exp. Date 6/28/2016 ; Service Code 2K8267 , Lot Number 160970143M , Exp. Date 7/6/2016 ; Service Code 2K8267 , Lot Number 161080249M , Exp. Date 7/17/2016 ; Service Code 2K8638 , Lot Number 160410229M , Exp. Date 5/11/2016 ; Service Code 2K8638 , Lot Number 160420200M , Exp. Date 5/12/2016 ; Service Code 2K8638 , Lot Number 160460214M , Exp. Date 5/16/2016 ; Service Code 2K8638 , Lot Number 160480210M , Exp. Date 5/17/2016 ; Service Code 2K8638 , Lot Number 160490254M , Exp. Date 5/19/2016 ; Service Code 2K8638 , Lot Number 160490255M , Exp. Date 5/19/2016 ; Service Code 2K8638 , Lot Number 160520127M , Exp. Date 5/22/2016 ; Service Code 2K8638 , Lot Number 160600310M , Exp. Date 5/30/2016 ; Service Code 2K8638 , Lot Number 160630164M , Exp. Date 6/2/2016 ; Service Code 2K8638 , Lot Number 160670272M , Exp. Date 6/6/2016 ; Service Code 2K8638 , Lot Number 160750259M , Exp. Date 6/14/2016 ; Service Code 2K8638 , Lot Number 160770264M , Exp. Date 6/16/2016 ; Service Code 2K8638 , Lot Number 160840238M , Exp. Date 6/23/2016 ; Service Code 2K8638 , Lot Number 160870197M , Exp. Date 6/26/2016 ; Service Code 2K8638 , Lot Number 160950189M , Exp. Date 7/4/2016 ; Service Code 2K8983 , Lot Number 160530047C , Exp. Date 5/14/2016 ; Service Code 2K8983 , Lot Number 160740088C , Exp. Date 6/4/2016 ; Service Code 2K8983 , Lot Number 160880066C , Exp. Date 6/18/2016 ; Service Code 2K8983 , Lot Number 160970040C , Exp. Date 6/27/2016 ;