Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

6,275 results found for sterility Page 19 of 251
Central Admixture Pharmacy Services, Inc.
Class II Terminated
dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0953-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, 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. Validation data for decontamination cycles is lacking.
D-0961-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0968-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0954-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1045-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0102-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1032-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, 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-1006-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6060-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0989-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8097-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0987-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1078-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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: 7...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0997-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2040-4
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1080-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 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-1041-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1043-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services Inc
Class II Terminated
lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1074-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, 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-1011-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **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-0998-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, IV Bag, Total Volume = 1818 mL, CRYSTALLOID INDUCTION, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0216-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1015-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, IV Bag, total volume = 522.8 mL, 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-1024-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume = 810 mL, 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-1036-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV Bag, total volume = 542 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-1018-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1046-2023 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 and HEPARIN, total volume = 250mL, IV Bag, 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-0993-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1071-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6065-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0982-2023 August 9, 2023 Phoenix, AZ