FDA recall D-1240-2019

CMC Enterprise Pharmacy · Class II · drug

Product

DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sodium Bicarbonate 8.4%-Lidocaine 1%-1:1 Dilution-26 mL, Magnesium Sulfate 500 mg/mL-4 mL, Cardiac Perfusion Only - Not for IV Use, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Reason for recall

Lack of sterility assurance.

Distribution

NC

Key facts

Status
Terminated
Initiation date
2019-04-12
Report date
2019-05-01
Termination date
2019-10-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Charlotte, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1240-2019