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FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated Aug 30, 2023

Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by…

Reason Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

VistaPharm LLC NDC 66689-305-16 D-1149-2023

Class II · Moderate risk Terminated Aug 25, 2023

Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New…

Reason Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets…

Marlex Pharmaceuticals, Inc. NDC 10135-0748-01 D-1170-2023

Class II · Moderate risk Terminated Aug 24, 2023

Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for…

Reason CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.

Baxter Healthcare Corporation NDC 0338-0067-01 D-0048-2024

Class II · Moderate risk Terminated Aug 22, 2023

Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous…

Reason Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).

Sofie Co dba Sofie NDC 54828-001-50 D-1177-2023

Class II · Moderate risk Terminated Aug 17, 2023

dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1138-2023

Class II · Moderate risk Terminated Aug 17, 2023

dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1137-2023

Class II · Moderate risk Terminated Aug 17, 2023

vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy Services…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1136-2023

Class II · Moderate risk Terminated Aug 17, 2023

heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1135-2023

Class II · Moderate risk Terminated Aug 17, 2023

oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1134-2023

Class II · Moderate risk Terminated Aug 17, 2023

oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1133-2023

Class II · Moderate risk Terminated Aug 17, 2023

oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1132-2023

Class II · Moderate risk Terminated Aug 17, 2023

EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1131-2023

Class II · Moderate risk Terminated Aug 17, 2023

EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1130-2023

Class II · Moderate risk Terminated Aug 17, 2023

EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1129-2023

Class II · Moderate risk Terminated Aug 17, 2023

PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1128-2023

Class II · Moderate risk Terminated Aug 17, 2023

PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1127-2023

Class II · Moderate risk Terminated Aug 17, 2023

PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1126-2023

Class II · Moderate risk Terminated Aug 17, 2023

PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1125-2023

Class II · Moderate risk Terminated Aug 17, 2023

PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1124-2023

Class II · Moderate risk Terminated Aug 17, 2023

CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1123-2023

Class II · Moderate risk Terminated Aug 17, 2023

Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1122-2023

Class II · Moderate risk Terminated Aug 17, 2023

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1121-2023

Class II · Moderate risk Terminated Aug 17, 2023

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with low calcium and HEPARIN, IV Bag, total volume =…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1120-2023

Class II · Moderate risk Terminated Aug 17, 2023

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with low calcium and HEPARIN, IV Bag, total volume =…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1119-2023

Class II · Moderate risk Terminated Aug 17, 2023

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1118-2023