Pharmedium Services, LLC recalls 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1
Recalled July 27, 2016 · FDA recall D-1372-2016 · Pharmedium Services
Hazard
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. · FDA Class II
Units
866 bags
Sold at
Nationwide
Description
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Product
0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)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 →