2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Recall Number: D-1405-2016

Firm: Pharmedium Services, LLC

Classification: Class II

Status: Terminated

Report Date: 20160727

Initiation Date: 20160505

Termination Date: 20180306

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141