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High RiskFDA
Plastikon Healthcare Llc
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional...
Drugs·92,200 affected·Jun 7, 2022
High RiskFDA
Plastikon Healthcare Llc
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cup...
Oral Drugs·88,500 affected·Jun 7, 2022
High RiskFDA
Plastikon Healthcare Llc
CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL indiv...
Drugs·1,464 affected·Jun 7, 2022
High RiskFDA
Plastikon Healthcare Llc
Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only,...
Oral Drugs·3,507,740 affected·Jun 7, 2022
High RiskFDA
Plastikon Healthcare Llc
CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, ...
Oral Drugs·49,280 affected·Jun 7, 2022
High RiskFDA
Plastikon Healthcare Llc
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays ...
Drugs·521,700 affected·Jun 7, 2022
High RiskFDA
Plastikon Healthcare Llc
CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, D...
Drugs·7,200 affected·Jun 7, 2022
High RiskFDA
Plastikon Healthcare Llc
MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional...
Drugs·502,600 affected·Jun 7, 2022
High RiskFDA
Plastikon Healthcare Llc
CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 1...
Drugs·1,464 affected·Jun 7, 2022
High RiskFDA
Plastikon Healthcare Llc
GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use On...
Drugs·280,500 affected·Jun 7, 2022
High RiskFDA
Plastikon Healthcare Llc
GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Onl...
Drugs·246,200 affected·Jun 7, 2022
High RiskFDA
Davol, Inc.
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, C...
Medical Devices·4,780 affected·Jun 7, 2022
High RiskFDA
Davol, Inc.
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubi...
Medical Devices·4,780 affected·Jun 7, 2022
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, O...
Oral Drugs·687 affected·Jun 6, 2022
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City,...
Oral Drugs·1,320 affected·Jun 6, 2022
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, O...
Oral Drugs·1,441 affected·Jun 6, 2022
High RiskFDA
Medline Industries, Lp - Spt
Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. ...
Cardiac Devices·1,960 affected·Jun 6, 2022
High RiskFDA
Medline Industries, Lp - Spt
Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ9058...
Medical Devices·288 affected·Jun 6, 2022
High RiskFDA
Medline Industries, Lp - Spt
Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A...
Medical Devices·1,880 affected·Jun 6, 2022
High RiskFDA
Medline Industries, Lp - Spt
Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SP...
Medical Devices·2,850 affected·Jun 6, 2022
High RiskFDA
Abbott Laboratories
Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L***INGREDIEN...
Beverages·50,502 affected·Jun 3, 2022
High RiskFDA
Bakery Barn, Llc
1st Phorm High Quality Protein Level-1 Bar Chocolate Crunch Protein Bars. 15 Bars Per Box. Net Wt. 12-2.22oz (63g) Bars 33.3oz (945g) Pe...
Snacks & Candy·1,500 affected·Jun 3, 2022
High RiskFDA
Klondike Cheese Company
Boar's Head Brand Spinach Greek Yogurt Dip. packaged in plastic container with lid. Net Wt. 12oz. UPC 42421-16282. Keep Refrigerated....
Dairy·12,365 affected·Jun 3, 2022
High RiskFDA
Bix Produce Company Llc
Bix Produce Diced Spinach, Item # 15939. packaged in 2lb bags, with 5 bags per case
Produce·1,181 affected·Jun 3, 2022
High RiskFDA
Sun Pharmaceutical Industries Inc
Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranb...
Injectable Drugs·27 affected·Jun 3, 2022
High RiskFDA
Sun Pharmaceutical Industries Inc
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industrie...
Injectable Drugs·97,450 affected·Jun 3, 2022
High RiskFDA
Sun Pharmaceutical Industries Inc
Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, D...
Oral Drugs·4,608 affected·Jun 3, 2022
High RiskFDA
Ambu Inc.
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 4123710...
Medical Devices·12,921 affected·Jun 3, 2022
High RiskFDA
Roi Cps Llc
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Medical Devices·86 affected·Jun 3, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Medical Polypectomy Snare, Catalog No. 7202
Medical Devices·45 affected·Jun 3, 2022
High RiskFDA
Wilton Industries Inc
Wilton Rainbow Sprinkles Mix net wt 5.92 oz. item number 710-0-0627
Food·16,281 affected·Jun 2, 2022
High RiskFDA
Wilton Industries Inc
Wilton Rainbow Chip Crunch Sprinkles net wt 5.25 oz. item 710-5364
Snacks & Candy·6,400 affected·Jun 2, 2022
High RiskFDA
Wright Medical Technology, Inc.
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle Sy...
Medical Devices·35 affected·Jun 2, 2022
High RiskFDA
Changzhou Biomet Medical Devices Co., Ltd.
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving ...
Medical Devices·0 affected·Jun 2, 2022
High RiskFDA
Ge Healthcare, Llc
Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite...
Medical Devices·24,843 affected·Jun 2, 2022
High RiskFDA
Breas Medical, Inc.
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanic...
Respiratory Devices·1,113 affected·Jun 2, 2022
High RiskFDA
Skytron, Div. The Kmw Group, Inc
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
Medical Devices·731 affected·Jun 2, 2022
High RiskFDA
Taylor Farms Retail Inc
Trader Joe's BBQ & Black Pepper Toscano Chopped Salad 11 oz. Contains Milk, Soy, Wheat Dist. & Sold Exclusively By: Trader Joe's, Monrovi...
Dairy·22,140 affected·Jun 1, 2022
High RiskFDA
Spectranetics Corporation
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Medical Devices·105 affected·Jun 1, 2022
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagu...
Diagnostic Devices·263 affected·Jun 1, 2022
High RiskFDA
Raysearch Laboratories Ab
RayStation 9B SP1. For radiation treatment planning.
Medical Devices·1 affected·Jun 1, 2022
High RiskFDA
Thistle Health Inc
Thistle Watermelon Berry Cold-Pressed Organic Juice watermelon strawberry lime chia 32 FL OZ (355 mL) Keep Refrigerated Distributed By: ...
Beverages·965 affected·May 31, 2022
High RiskFDA
Thistle Health Inc
Thistle Tropical Limeade Cold-Pressed Organic Juice watermelon pineapple lime strawberry papaya activated charcoal 32 FL OZ (355 mL) Keep...
Beverages·1,003 affected·May 31, 2022
High RiskFDA
Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver, Model: 96280
Medical Devices·529 affected·May 31, 2022
High RiskFDA
Baxter Healthcare Corporation
NaviCare Nurse Call/Voalte Nurse Call
Medical Devices·283 affected·May 31, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic...
Medical Devices·163 affected·May 31, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic...
Medical Devices·656 affected·May 31, 2022
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Medical Devices·32 affected·May 30, 2022