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High RiskFDA
Edge Pharma, Llc
Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular In...
Injectable Drugs·0 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT...
Topical Drugs·74 affected·Dec 6, 2021
High RiskFDA
Medique Products
Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactu...
Oral Drugs·6,639,838 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856 Hercules Dr., Col...
Inhaled / Nasal Drugs·231 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-...
Injectable Drugs·1,795 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Int...
Injectable Drugs·168 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count bottle, For Ot...
Oral Drugs·1,055 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colches...
Injectable Drugs·457 affected·Dec 6, 2021
High RiskFDA
Medique Products
Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packe...
Oral Drugs·16,630,118 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Col...
Inhaled / Nasal Drugs·114 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC ...
Injectable Drugs·5,335 affected·Dec 6, 2021
High RiskFDA
Abbott Molecular, Inc.
Alinity m System, Part No. 08N53-002
Medical Devices·742 affected·Dec 6, 2021
High RiskFDA
Valgene Incorporated Dba Cape Drugs
B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Injectable Drugs·12 affected·Dec 3, 2021
High RiskFDA
Valgene Incorporated Dba Cape Drugs
Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Injectable Drugs·27 affected·Dec 3, 2021
High RiskFDA
Wright Medical Technology Inc
Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
Medical Devices·250 affected·Dec 3, 2021
High RiskFDA
Wright Medical Technology, Inc.
Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstructi...
Medical Devices·22 affected·Dec 3, 2021
High RiskFDA
Konica Minolta Healthcare Americas, Inc.
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for me...
Diagnostic Devices·30 affected·Dec 3, 2021
High RiskFDA
Torrent Pharma Inc.
Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, Indi...
Oral Drugs·15,336 affected·Dec 2, 2021
High RiskFDA
Philips Medical Systems Nederland B.v.
Zenition 50, Model #718096
Medical Devices·16 affected·Dec 2, 2021
High RiskFDA
Livanova Usa, Inc.
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) ...
Medical Devices·10 affected·Dec 2, 2021
High RiskFDA
Natus Neurology Dba Excel Tech., Ltd. (xltek)
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Medical Devices·221 affected·Dec 2, 2021
High RiskFDA
Philips Medical Systems Nederland B.v.
Veradius Unity, Model #718132
Medical Devices·12 affected·Dec 2, 2021
High RiskFDA
Livia Global
Livia One Organic Daily Topical Spray Probiotics; 4 oz. (120 ml) UPC: 0 30915 10710 5 Recommended use: Topical: Spray affected are...
Beverages·571 affected·Dec 1, 2021
High RiskFDA
Livia Global
Livia One Organic Probiotic Nasal Spray; 1 oz. (30 ml) UPC: 0 30915 10719 8 Suggested use: Adult - 102 pumps in each nostril as ne...
Beverages·1,130 affected·Dec 1, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human s...
Diagnostic Devices·46 affected·Dec 1, 2021
High RiskFDA
Maquet Cardiovascular, Llc
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Medical Devices·2 affected·Dec 1, 2021
High RiskFDA
Medline Industries, Lp - Northfield
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Diagnostic Devices·100 affected·Dec 1, 2021
High RiskFDA
Frozen Food Development
Giant Eagle, Diced Green Peppers, 10 oz. poly bags and 22# cases, also poly bags and cartons, 12/10 oz. bags per case and bulk 22 lbs. bags
Food·20,825 affected·Nov 30, 2021
High RiskFDA
Golden Lab Llc
DoctoRx's Optimal Formula, Dry Eye Formula, Ocular Support Softgel, 60 Softgels/Dietary Supplement
Baby Food & Formula·13,079 affected·Nov 30, 2021
High RiskFDA
Teligent Pharma, Inc.
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Phar...
Topical Drugs·7,176 affected·Nov 30, 2021
High RiskFDA
Pfizer Inc.
5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/04...
Injectable Drugs·765 affected·Nov 30, 2021
High RiskFDA
Activbody, Inc.
Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics...
Medical Devices·501 affected·Nov 30, 2021
High RiskFDA
Roi Cps Llc
Regard, T AND A - Rogers, sterilized convenience kits
Medical Devices·195 affected·Nov 30, 2021
High RiskFDA
Straumann Usa Llc
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Medical Devices·1 affected·Nov 30, 2021
High RiskFDA
Straumann Usa Llc
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Medical Implants·7 affected·Nov 30, 2021
High RiskFDA
Krispy Kreme Doughnut Corporatio
Krispy Kreme DOUGHNUT Bites ORIGINAL GLAZED 5 1.6 OZ (45g) POUCHES NET WT. 8 OZ (227g) Manufactured under the authority of Krispy Kreme D...
Food·2,108 affected·Nov 29, 2021
High RiskFDA
Mitsubishi International Food Ingredients, Inc.
Yeast Extract Ajirex in 15 kg PE bag in carton box
Food·90 affected·Nov 29, 2021
High RiskFDA
Giant Eagle, Inc.
Giant Eagle Diced Green Peppers, 10 oz. 283 g, Frozen bag, 12 packages per case , Best By 10/14/2023 .
Frozen Food·699 affected·Nov 29, 2021
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englew...
Injectable Drugs·1,440 affected·Nov 29, 2021
High RiskFDA
Preferred Pharmaceuticals, Inc.
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, I...
Topical Drugs·72 affected·Nov 29, 2021
High RiskFDA
Ultratab Laboratories, Inc.
PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with ...
Oral Drugs·14 affected·Nov 29, 2021
High RiskFDA
Philips North America Llc
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Medical Devices·2,925,800 affected·Nov 29, 2021
High RiskFDA
Philips North America Llc
Heel Snuggler, Reference # 989805603411 99047
Medical Devices·2,509,100 affected·Nov 29, 2021
High RiskFDA
Ion Beam Applications S.a.
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Medical Devices·5 affected·Nov 29, 2021
High RiskFDA
Philips North America Llc
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Medical Devices·5,164,600 affected·Nov 29, 2021
High RiskFDA
Philips North America Llc
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Medical Devices·4,920,600 affected·Nov 29, 2021
High RiskFDA
Philips North America Llc
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Medical Devices·141,744 affected·Nov 26, 2021
High RiskFDA
Cesarina Bakery, Inc
Cesarina Cookies, Assorted Cookies, Net Weight 16oz (453.59g)
Bakery & Grains·455 affected·Nov 24, 2021