Pharmedium Services, LLC recalls 5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hosp
Recalled July 27, 2016 · FDA recall D-1429-2016 · Pharmedium Services
Hazard
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. · FDA Class II
Units
445 bags
Sold at
Nationwide
Description
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Product
5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), 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 →