Pharmedium Services, LLC recalls 10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoj
Recalled July 27, 2016 · FDA recall D-1381-2016 · Pharmedium Services
Hazard
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. · FDA Class II
Units
600 Monoject Syringes
Sold at
Nationwide
Description
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Product
10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Manufacturer(s)
Pharmedium Services, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →