PharMEDium Services, LLC recalls 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fenta
Recalled August 15, 2018 · FDA recall D-1043-2018 · PharMEDium Services
Hazard
CGMP deviations: Product was released while a hood certification discrepancy was being investigated. · FDA Class II
Units
230 Intravia Bags
Sold at
Product was distributed throughout the United States
Description
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Product
10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.
Manufacturer(s)
PharMEDium Services, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →