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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 261–280 of 1,000 recalls

Class IITerminated

fentaNYL in 0.9% sodium chloride, 5,000 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

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

PHENYLephrine in 0.9% sodium chloride, 1,000 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 71286-6009-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

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

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511.

BE PHARMACEUTICALS AG

Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.

September 5, 2023 · DrugView details →

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 →

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