FDA recalls, February 2014: 375 published

147 different companies appear this month.

Risk classification: Class I: 32 · Class II: 321 · Class III: 22

Same month, other agencies:FSIS 10 recallsNHTSA 53 recalls

Recalls this month

DateProduct
February 12, 2014Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-10). The p…D-1073-2014PACK Pharmaceuticals, LLC
February 12, 2014HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: …D-1067-2014Health & Beyond
February 12, 2014Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The…D-1071-2014PACK Pharmaceuticals, LLC
February 12, 2014Neptune 2 Rover Ultra Waste Management System.Z-0902-2014Stryker Instruments Div. of Stryker Corporation
February 12, 2014Triarco Industries, LLC an Innophos company Green Lightening Drink Granulation Notice -…F-1470-2014Triarco Industries, Inc.
February 12, 2014Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in…D-1075-2014Teva Pharmaceuticals USA
February 12, 2014Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE…Z-0914-2014GE Healthcare
February 12, 2014B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery …Z-0921-2014B. Braun Medical, Inc.
February 12, 2014The Gaymar Medi-Therm device provides a means of regulating patient temperature by supply…Z-0933-2014Stryker Medical Division of Stryker Corporation
February 12, 2014Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are use…Z-0908-2014Medtronic Cardiovascular Surgery-the Heart Valve Division
February 12, 2014ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitr…Z-0929-2014Siemens Healthcare Diagnostics, Inc
February 12, 2014Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test inte…Z-0937-2014ITC-Nexus Dx
February 12, 2014Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Re…D-1074-2014Teva Pharmaceuticals USA
February 12, 2014Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and Di…D-1079-2014Corepharma LLC
February 12, 2014Neptune 2 Rover Ultra Waste Management SystemZ-0903-2014Stryker Instruments Div. of Stryker Corporation
February 12, 2014Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 92…Z-0931-2014CareFusion 303, Inc.
February 12, 2014LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a univer…Z-0935-2014Zest Anchors LLC
February 12, 2014Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (G…Z-0905-2014Medtronic Advanced Energy, LLC
February 12, 2014ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quali…Z-0904-2014Horiba Instruments, Inc dba Horiba Medical
February 12, 2014Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are pac…D-1068-2014PACK Pharmaceuticals, LLC
February 12, 2014Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labele…Z-0917-2014GE Healthcare
February 12, 2014Triarco Industries, LLC an Innophos company Red Lightening Drink Granulation Notice- Fo…F-1469-2014Triarco Industries, Inc.
February 12, 2014Heavenly Blue cheese; Packaged in clear plastic in sizes ranging from 1/2 lb to whole whe…F-1467-2014Flat Creek Farm & Dairy
February 12, 2014GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The…Z-0911-2014GE Healthcare, LLC
February 12, 2014Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2…Z-0916-2014GE Healthcare
February 12, 2014Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEM…Z-0932-2014Philips Medical Systems (Cleveland) Inc
February 12, 2014Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz…D-1076-2014Faria Limited LLC dba Sheffield Pharmaceuticals
February 12, 2014MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing…Z-0910-2014Nipro Diagnostics, Inc.
February 12, 2014CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: A…D-1062-2014Central Shared Services dba Parallon
February 12, 2014SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 coun…Z-0923-2014Highland Metals, Inc.
February 12, 2014ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and…Z-0924-2014Horiba Instruments, Inc dba Horiba Medical
February 12, 2014Dicopanol FusePaq Kit for Oral Suspension, 5mg/MLD-1055-2014Fusion Pharmaceuticals, LLC
February 12, 2014Triarco Industries, LLC an Innophos company Activessence (R) Notice- For Manufacturing …F-1471-2014Triarco Industries, Inc.
February 12, 2014Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only …D-1080-2014Dr. Reddy's Laboratories, Inc.
February 12, 2014Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part num…Z-0913-2014GE Healthcare
February 12, 2014SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors a…Z-0925-2014CareFusion 303, Inc.
February 12, 2014Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 …D-1054-2014B. Braun Medical Inc
February 12, 2014***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXA…Z-0906-2014Exactech, Inc.
February 12, 2014The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulati…Z-0936-2014Ossur Americas, Inc.
February 12, 2014The Rotoprone therapy System is an advanced patient care system for the treatment and pre…Z-0926-2014ArjoHuntleigh Inc.
February 12, 2014Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel …D-1061-2014Teva Pharmaceuticals USA, Inc.
February 12, 2014The firm is recalling all lots of sterile products compounded by the pharmacy that are wi…D-1066-2014Apothecure, Inc
February 5, 2014Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19g…Z-0891-2014Synergetics Inc
February 5, 2014eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Par…D-1047-2014SS Wholesale Inc. dba Jobbers Wholesale
February 5, 2014Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-secti…Z-0831-2014Philips Medical Systems (Cleveland) Inc
February 5, 2014Cheerful Cookie Combo containing an assortment of Lemon Butter Cookies and Famous Butter …F-1433-2014The Lambs Farm, Inc.
February 5, 201425ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12…Z-0885-2014Synergetics Inc
February 5, 2014Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Cod…Z-0859-2014Codman & Shurtleff, Inc.
February 5, 2014ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Ne…D-1038-2014The Mentholatum Co.
February 5, 2014Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, …Z-0847-2014Zimmer Dental Inc

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