PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0965-2023August 9, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6031-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0983-2023August 9, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with low calcium and HEPARIN, IV Bag, Total Volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenu...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0980-2023August 9, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0955-2023August 9, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/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-1010-2023August 9, 2023Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class IITerminated
PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1077-2023August 9, 2023San Diego, CA
Central Admixture Pharmacy Services Inc
Class IITerminated
HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1049-2023August 9, 2023San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class IITerminated
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6042-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0973-2023August 9, 2023Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class IITerminated
fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1063-2023August 9, 2023San Diego, CA
Central Admixture Pharmacy Services, Inc.
Class IITerminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Ph...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1004-2023August 9, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0218-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1025-2023August 9, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7019-1.
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0959-2023August 9, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml; IV Bag, Total Volume = 165 mL, 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-1026-2023August 9, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
CARDIOPLEGIA SOLUTION, 36 mEq K, Induction 4:1, High Potassium/Low tromethamine, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, ND...
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-1019-2023August 9, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
oxyTOCIN 20 units added to Lactated Ringer's 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6038-1
Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
D-0984-2023August 9, 2023Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class IITerminated
CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low 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-1039-2023August 9, 2023Phoenix, AZ
Central Admixture Pharmacy Services Inc
Class IITerminated
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbroo...
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1069-2023August 9, 2023San Diego, CA
Central Admixture Pharmacy Services Inc
Class IITerminated
PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009...
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1066-2023August 9, 2023San Diego, CA
Central Admixture Pharmacy Services Inc
Class IITerminated
fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1053-2023August 9, 2023San Diego, CA
Central Admixture Pharmacy Services Inc
Class IITerminated
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: 71286-2071-1
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1079-2023August 9, 2023San Diego, CA
Central Admixture Pharmacy Services Inc
Class IITerminated
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbro...
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
D-1067-2023August 9, 2023San Diego, CA
Sagent Pharmaceuticals
Class IIOngoing
Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals,...
Reason: Lack of Assurance of Sterility
D-0937-2023August 2, 2023Schaumburg, IL
Sagent Pharmaceuticals
Class IIOngoing
Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
Reason: Lack of Assurance of Sterility
D-0935-2023August 2, 2023Schaumburg, IL
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Class IIOngoing
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste ...
Reason: Lack of Assurance of Sterility
D-0944-2023August 2, 2023Louisville, KY
Sagent Pharmaceuticals
Class IIOngoing
Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made...