Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 9 of 87
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
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
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
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
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
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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-0965-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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-0983-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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-0980-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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-0955-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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-1010-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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-0973-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with 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-1004-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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-1025-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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-0959-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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-1026-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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-1019-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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-0984-2023 August 9, 2023 Phoenix, AZ
Central Admixture Pharmacy Services, Inc.
Class II Terminated
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-1039-2023 August 9, 2023 Phoenix, AZ
Global Pharma Healthcare Private Limited
Class I Ongoing
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 1...
Reason: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
D-0921-2023 July 19, 2023 Chennai, N/A