Home / Recalls / CMC Enterprise Pharmacy / D-1240-2019

D-1240-2019 Class II Terminated

Recalled by CMC Enterprise Pharmacy — Charlotte, NC

Recall Details

Product Type
Drugs
Report Date
May 1, 2019
Initiation Date
April 12, 2019
Termination Date
October 30, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
110 bags

Product Description

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 Pattern

NC

Code Information

Lots: ED041909 Exp. 4/13/2019; ED111907 Exp. 4/20/2019

Other recalls by CMC Enterprise Pharmacy

  • D-1235-2019 Class II — Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acr (April 12, 2019)
  • D-1211-2019 Class II — Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres (April 12, 2019)
  • D-1233-2019 Class II — Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 44 (April 12, 2019)
  • D-1215-2019 Class II — Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf (April 12, 2019)
  • D-1212-2019 Class II — Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 (April 12, 2019)
  • D-1213-2019 Class II — Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf (April 12, 2019)
  • D-1238-2019 Class II — Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharm (April 12, 2019)
  • D-1214-2019 Class II — Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf (April 12, 2019)
  • D-1227-2019 Class II — CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 G (April 12, 2019)
  • D-1225-2019 Class II — CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enter (April 12, 2019)