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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 281–300 of 1,000 recalls

Class IITerminated

Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16

VistaPharm LLC

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

August 30, 2023 · DrugView details →

Class IITerminated

Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01

Marlex Pharmaceuticals, Inc.

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, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

August 25, 2023 · DrugView details →

Class IITerminated

Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01

Baxter Healthcare Corporation

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

August 24, 2023 · DrugView details →

Class IITerminated

Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only, Manufactured by SOFIE Co dba SOFIE, Dulles, VA 20166 for Life Molecular Imagining Ltd., NDC 54828-001-50

Sofie Co dba Sofie

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

August 22, 2023 · DrugView details →

Class IITerminated

EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with low calcium and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0428-1

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with low calcium and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

Class IITerminated

CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →

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