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
Recall Number: D-1419-2016
Firm: Pharmedium Services, LLC
Classification: Class II
Status: Terminated
Report Date: 20160727
Initiation Date: 20160505
Termination Date: 20180306
Reason for Recall
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Product 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