FDA recall D-1044-2018

PharMEDium Services, LLC · Class II · drug

Product

5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, 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-1044-2018