FlaggedRx← Medication recall checkHome
Class II · ModerateRecall completed

DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Man

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots: ED041909 Exp. 4/13/2019; ED111907 Exp. 4/20/2019
Where it was soldNC
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of sterility assurance.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forCMC Enterprise Pharmacy
Show the full FDA record
Full product labelDelNido 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.
Recalling firmCMC Enterprise Pharmacy
DistributionNC
Quantity110 bags
Recall initiated2019-04-12
Report date2019-05-01
Recall completed2019-10-30
Recall numberD-1240-2019
ClassificationClass II
FDA statusTerminated
Origin on fileCharlotte NC United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.