Pharmedium Services, LLC recalls 3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxte
Recalled July 27, 2016 · FDA recall D-1413-2016 · Pharmedium Services
Hazard
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. · FDA Class II
Units
700 bags
Sold at
Nationwide
Description
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Product
3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K9217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-97
Manufacturer(s)
Pharmedium Services, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →