September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Serv
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Service
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Servic
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Service
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Service
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd A
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Phar
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total v
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volum
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250m
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Adm
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Ad
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue,
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL,
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Centr
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admix
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL,
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixtu
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixt
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
August 30, 2023DrugsFDA
TMC Acquisitions LLC dba Tailor Made Compounding recalls NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.
Hazard: Lack of Assurance of Sterility
August 30, 2023DrugsFDA
TMC Acquisitions LLC dba Tailor Made Compounding recalls Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
Hazard: Lack of Assurance of Sterility
August 30, 2023DrugsFDA
Inmar Supply Chain Solutions, LLC recalls All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
Hazard: CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.
August 30, 2023DrugsFDA
Baxter Healthcare Corporation recalls Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcar
Hazard: Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
August 30, 2023DrugsFDA
Ecometics, Inc. recalls Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials,
Hazard: CGMP Deviations: Products not manufactured under current good manufacturing practices.
August 30, 2023DrugsFDA
Ecometics, Inc. recalls AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06
Hazard: CGMP Deviations: Products not manufactured under current good manufacturing practices.
August 30, 2023DrugsFDA
Ecometics, Inc. recalls activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ
Hazard: CGMP Deviations: Products not manufactured under current good manufacturing practices.