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High RiskFDA
Altaire Pharmaceuticals, Inc.
Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#: 6-78112-15418-7
Drugs·0 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
iSolutions NanoTears HA Preservative Free Multi - Dose Lubricant Gel Drops Sterile, 0.33 FL OZ (10 mL), Manufactured by Altaire Pharmaceu...
Topical Drugs·137 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15
Ophthalmic Drugs·20,666 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsock...
Topical Drugs·0 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Twin Pack, Item#: 495323, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, I...
Ophthalmic Drugs·37,656 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct, Mfd. By: by Altaire ...
Topical Drugs·48,973 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x 15 mL, Distributed by: CVS Pharmacy, Inc. One C...
Topical Drugs·50,304 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Lubricant Eye Drops Moisturizing (Carboxymethycellulose Sodium 0.5% Eye Lubricant), 0.5 oz. (15 mL), Distributed by: Walgreens Co., 200 W...
Ophthalmic Drugs·35,896 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g
Topical Drugs·0 affected·Jul 2, 2019
High RiskFDA
Lupin Pharmaceuticals Inc.
Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distri...
Oral Drugs·12,938 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL
Ophthalmic Drugs·73,548 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonv...
Ophthalmic Drugs·557,376 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77...
Ophthalmic Drugs·88,008 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief, Sterile, 0.33 fl. oz. (10 mL), Item #968210, Distributed b...
Ophthalmic Drugs·66,159 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl. oz. (15 mL), Item #317916, Distributed by: CVS Pharmacy, I...
Ophthalmic Drugs·365,832 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altai...
Drugs·103,856 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA, Mfd. By: Altaire Ph...
Drugs·90,072 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville,...
Topical Drugs·469,128 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Item#: 634634, Product Size: 0.6 mL x 30, Distributed by: CVS Pharmacy, ...
Topical Drugs·114,504 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Item#: 994882, Product Size: 0.6 mL x 24 ct, Distributed by: CVS Pharmacy, ...
Ophthalmic Drugs·58,704 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocke...
Topical Drugs·24,024 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, ...
Topical Drugs·0 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL, NDC 49035-882-52
Topical Drugs·0 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., ...
Ophthalmic Drugs·483,528 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pharmaceuticals Inc., Aquebogue, NY 11931, NDC 59390-183-13
Drugs·22,494 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.5 oz (15 mL), Distributed by : Walgreen Co 200 Wilmot Road D...
Ophthalmic Drugs·43,008 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 7740...
Drugs·14,091 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perri...
Topical Drugs·1,737,549 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13
Drugs·48,542 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY ...
Ophthalmic Drugs·306,479 affected·Jul 2, 2019
High RiskFDA
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
Medical Devices·23 affected·Jul 2, 2019
High RiskFDA
Cincinnati Sub-zero Products Llc, A Gentherm Company
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compr...
Medical Devices·5,291 affected·Jul 2, 2019
High RiskFDA
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811
Medical Devices·28 affected·Jul 2, 2019
High RiskFDA
Qiagen Sciences Llc
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automate...
Medical Devices·417 affected·Jul 2, 2019
High RiskFDA
Cincinnati Sub-zero Products Llc, A Gentherm Company
Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is compos...
Medical Devices·3,932 affected·Jul 2, 2019
High RiskFDA
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815
Medical Devices·19 affected·Jul 2, 2019
High RiskFDA
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
Medical Devices·29 affected·Jul 2, 2019
High RiskFDA
Ge Healthcare, Llc
Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
Medical Devices·3 affected·Jul 2, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in...
Diagnostic Devices·4,309 affected·Jul 2, 2019
High RiskFDA
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813
Medical Devices·39 affected·Jul 2, 2019
High RiskFDA
Mazor Robotics Ltd
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Medical Devices·93 affected·Jul 2, 2019
High RiskFDA
Ge Healthcare, Llc
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
Medical Devices·2 affected·Jul 2, 2019
High RiskFDA
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814
Medical Devices·30 affected·Jul 2, 2019
High RiskFDA
Bento Sushi
Bento Express Fully Cooked Pink Salmon in a Teriyaki Sauce with Snow Peas, Garnished with Sesame Seeds. Served on Steamed White Rice, UPC...
Seafood·36 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for ...
Medical Devices·6,180 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient pop...
Medical Devices·3,250 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on newborns.
Medical Devices·220 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to faci...
Medical Devices·2,019,041,790 affected·Jul 1, 2019