All Recalls

92,900 total recalls in our database

Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03

KENIL HEALTHCARE PRIVATE LIMITED

💊 Drugs Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94

Zydus Pharmaceuticals (USA)

💊 Drugs Class I - Dangerous

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

May 13, 2025 Prescription Drugs Nationwide View Details →

Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01

KENIL HEALTHCARE PRIVATE LIMITED

💊 Drugs Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02

KENIL HEALTHCARE PRIVATE LIMITED

💊 Drugs Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-07

KENIL HEALTHCARE PRIVATE LIMITED

💊 Drugs Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.

KVK Tech

💊 Drugs Class I - Dangerous

cGMP deviations

May 9, 2025 Prescription Drugs Nationwide View Details →

CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052.

KENIL HEALTHCARE PRIVATE LIMITED

💊 Drugs Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0.

KENIL HEALTHCARE PRIVATE LIMITED

💊 Drugs Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-440-02, UPC 8 10096 77162 9.

KENIL HEALTHCARE PRIVATE LIMITED

💊 Drugs Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3.

KENIL HEALTHCARE PRIVATE LIMITED

💊 Drugs Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Over-the-Counter View Details →

Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01

KENIL HEALTHCARE PRIVATE LIMITED

💊 Drugs Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.

CareFusion 213

💊 Drugs Class I - Dangerous

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

May 15, 2025 Compounded Drugs Nationwide View Details →

CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4.

KENIL HEALTHCARE PRIVATE LIMITED

💊 Drugs Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740

C.R. Bard

🏥 Medical Devices Class I - Dangerous

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Apr 17, 2025 Other Medical Devices Nationwide View Details →

TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.

Echopixel

🏥 Medical Devices Class I - Dangerous

Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.

Apr 11, 2016 Other Medical Devices Nationwide View Details →

Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;

Philips North America

🏥 Medical Devices Class I - Dangerous

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

May 13, 2025 Other Medical Devices Nationwide View Details →

Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,

Cook Incorporated

🏥 Medical Devices Class I - Dangerous

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

Apr 17, 2025 Other Medical Devices Nationwide View Details →

Product Name: Ingenia 3.0T CX; Model Number: 781271;

Philips North America

🏥 Medical Devices Class I - Dangerous

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

May 13, 2025 Other Medical Devices Nationwide View Details →

Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter

Centerline Biomedical

🏥 Medical Devices Class I - Dangerous

Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.

Apr 11, 2025 Surgical Instruments View Details →

Product Name: Ingenia 1.5T CX; Model Number: 781262;

Philips North America

🏥 Medical Devices Class I - Dangerous

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

May 13, 2025 Other Medical Devices Nationwide View Details →