Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

6,275 results found for sterility Page 22 of 251
Central Admixture Pharmacy Services Inc
Class II Terminated
HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2013-1
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1057-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services Inc
Class II Terminated
fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1061-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
EPINEPHrine added to dextrose 5%, 4mg/250ml, 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. Validation data for decontamination cycles is lacking.
D-0958-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1059-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6078-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0970-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 238.75 mL, 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-1023-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1012-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1.
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0963-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
morphine 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 71286-2040-3
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1065-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheon...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1002-2023 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, total volume = 250mL, IV Bag, 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-1007-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0948-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Av...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1001-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1058-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services Inc
Class II Terminated
morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-1
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1064-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
vancomycin 1.5 g/250 mL added to 0.9% sodium chloride, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6076-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0966-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1062-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services Inc
Class II Terminated
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1050-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services Inc
Class II Terminated
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road,...
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1072-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheon...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1027-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0986-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
oxyTOCIN 30 units added to dextrose 5%/lactated ringers 500 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6032-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1003-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class II Terminated
HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-20...
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1044-2023 August 9, 2023 San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/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-1014-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1013-2023 August 9, 2023 Phoenix, AZ