January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin,
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Bo
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use On
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-089
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryla
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 0079
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippa
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA;
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmed
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suit
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactur
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madiso
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 0880
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540.
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC,
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactu
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
GlaxoSmithKline LLC recalls ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters
Hazard: Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
December 27, 2023DrugsFDA
Blistex Inc recalls Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-464
Hazard: Chemical contamination: Presence of benzene
December 27, 2023DrugsFDA
Noah's Wholesale LLC recalls THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions
Hazard: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
December 27, 2023DrugsFDA
Fagron, Inc recalls NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron,
Hazard: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.