Pharmedium Services, LLC recalls 1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow
Recalled July 27, 2016 · FDA recall D-1373-2016 · Pharmedium Services
Hazard
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. · FDA Class II
Units
40 Medical Cassettes
Sold at
Nationwide
Description
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Product
1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassettes, Service Code 2T8175 Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-175-48
Manufacturer(s)
Pharmedium Services, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →