FDA-Drug2018-08-15Class II
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.
PharMEDium Services, LLC
Hazard
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Sold states
Product was distributed throughout the United States
Affected count
230 Intravia Bags
Manufactured in
36 Stults Rd, N/A, Dayton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1043-2018Don't want to check this manually?
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