Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

6,275 results found for sterility Page 21 of 251
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Ch...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0956-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue,...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1008-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
potassium phosphate, 30 mmole added to 0.9% sodium Chloride 500mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7016-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0990-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010...
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1052-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer's Low Potassium, IV Bag, total volume = 504.8 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 850...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1035-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6084-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0952-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/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. Validation data for decontamination cycles is lacking.
D-0995-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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. Validation data for decontamination cycles is lacking.
D-0957-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6176-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0967-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1021-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue,...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0996-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2041-2
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1068-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 8...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0992-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1073-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/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. Validation data for decontamination cycles is lacking.
D-0991-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextrose, IV Bag, total volume = 500 mL, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 8...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1031-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 D...
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1070-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheoni...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1038-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1056-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0950-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, ...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1020-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 8504...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1033-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0962-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1055-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 mcg/mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-8095-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0988-2023 August 9, 2023 Phoenix, AZ