Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

6,275 results found for sterility Page 18 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:Lack of validation data for sanitization cycles
D-1137-2023 September 6, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72...
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1110-2023 September 6, 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:Lack of validation data for sanitization cycles
D-1121-2023 September 6, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1124-2023 September 6, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1128-2023 September 6, 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:Lack of validation data for sanitization cycles
D-1116-2023 September 6, 2023 Phoenix, AZ
Baxter Healthcare Corporation
Class II Terminated
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container...
Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
D-1140-2023 September 6, 2023 Deerfield, IL
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:Lack of validation data for sanitization cycles
D-1122-2023 September 6, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), 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:Lack of validation data for sanitization cycles
D-1130-2023 September 6, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
D-1138-2023 September 6, 2023 Phoenix, AZ
TMC Acquisitions LLC dba Tailor Made Compounding
Class II Terminated
Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
Reason: Lack of Assurance of Sterility
D-1105-2023 August 30, 2023 Nicholasville, KY
TMC Acquisitions LLC dba Tailor Made Compounding
Class II Terminated
NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.
Reason: Lack of Assurance of Sterility
D-1106-2023 August 30, 2023 Nicholasville, KY
Central Admixture Pharmacy Services, Inc.
Class II Terminated
heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7022-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0978-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1075-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0985-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
rocuronium50 mg/5 mL (10 mg/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. Validation data for decontamination cycles is lacking.
D-0947-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0951-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride, (3 mg/mL), IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6071-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0971-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 4...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1029-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 5% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx Only, 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-0994-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1054-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central 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-1017-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1022-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6012-1.
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1048-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
heparin 2500 units/500mL added to 0.9% sodium chloride 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. Validation data for decontamination cycles is lacking.
D-0977-2023 August 9, 2023 Phoenix, AZ