Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

6,275 results found for sterility Page 20 of 251
Central Admixture Pharmacy Services Inc
Class II Terminated
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1047-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1034-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:72196-6037-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0975-2023 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 **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1005-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1051-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-70...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0964-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7023-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0979-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0981-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 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. Validation data for decontamination cycles is lacking.
D-0960-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 7219...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1040-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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. Validation data for decontamination cycles is lacking.
D-1000-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, 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-1037-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1060-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 721...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1016-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
heparin 2500 units added to 0.9% sodium chloride 250mL, CONCENTRATION = 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-80...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0974-2023 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 HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1009-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1076-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
oxyTOCIN 10 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: 72196-6036-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0972-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7060-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0969-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6043-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0976-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 830 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1028-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue Pheonix, AZ, NDC 72196-6011-2.
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0949-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2001-2
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1042-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, 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-1030-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/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-0999-2023 August 9, 2023 Phoenix, AZ