Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in...
Reason: Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
D-1148-2023September 20, 2023Zug
Central Admixture Pharmacy Services, Inc.
Class IITerminated
PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1126-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1125-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Ph...
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1117-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-...
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1123-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, P...
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1118-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd A...
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1119-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sul...
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1112-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1133-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1113-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheo...
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1109-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1136-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1135-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue...
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1114-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1131-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43...
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1120-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:...
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1115-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1127-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 7219...
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1108-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1132-2023September 6, 2023Phoenix, AZ
Baxter Healthcare Corporation
Class IITerminated
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193...
Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
D-1141-2023September 6, 2023Deerfield, IL
Central Admixture Pharmacy Services, Inc.
Class IITerminated
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 721...
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1107-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1129-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1134-2023September 6, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043,...
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles