FDA recall D-1043-2018

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.

Reason for recall

CGMP deviations: Product was released while a hood certification discrepancy was being investigated.

Distribution

Product was distributed throughout the United States

Key facts

Status

Terminated

Initiation date

2018-07-24

Report date

2018-08-15

Termination date

2018-12-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dayton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1043-2018