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High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·2,698 affected·Mar 17, 2020
CriticalFDA
Mountain Rose Inc. Dba Mountain Rose Herbs
Kudzu Root (Pueraria montana var. lobata), This product was packaged in a clear plastic bag or poly-woven bags sold in bulk form net weig...
Supplements·24,247 affected·Mar 16, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95
Oral Drugs·446,628 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 7...
Injectable Drugs·2,475 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave....
Injectable Drugs·1,500 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis ...
Injectable Drugs·900 affected·Mar 16, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tr...
Oral Drugs·471,024 affected·Mar 16, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Conges...
Drugs·566 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject ...
Injectable Drugs·290 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road D...
Injectable Drugs·75 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium...
Injectable Drugs·1,840 affected·Mar 16, 2020
High RiskFDA
The Medicine Shoppe Pharmacy
Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952
Drugs·4 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis ...
Injectable Drugs·1,350 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. D...
Injectable Drugs·1,075 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Fr...
Injectable Drugs·4,625 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC ...
Injectable Drugs·80 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, L...
Drugs·210 affected·Mar 16, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 01...
Topical Drugs·4,104 affected·Mar 16, 2020
CriticalFDA
Y-o Management Llc, Dba Natural Remedy Store
Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(87...
Supplements·19,156 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Da...
Injectable Drugs·375 affected·Mar 16, 2020
High RiskFDA
Pharmedium Services, Llc
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-3...
Injectable Drugs·2,250 affected·Mar 16, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0...
Oral Drugs·151,056 affected·Mar 16, 2020
CriticalFDA
Dr. Reddy's Laboratories, Inc.
Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC ...
Injectable Drugs·10,943 affected·Mar 16, 2020
CriticalFDA
Vascular Solutions, Inc.
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Surgical Devices·30,877 affected·Mar 16, 2020
High RiskFDA
Avanos Medical, Inc.
CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Medical Devices·1,766 affected·Mar 16, 2020
High RiskFDA
Life Technologies Corporation
Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Ca...
Medical Devices·66 affected·Mar 16, 2020
High RiskFDA
Life Technologies Corporation
Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens,...
Medical Devices·35 affected·Mar 16, 2020
High RiskFDA
Winco Foods Llc
WinCo Foods frozen Berry Medley (Strawberries, Blackberries, Raspberries and Blueberries), item# 107412, packaged in polyethylene bags. P...
Produce·21,264 affected·Mar 13, 2020
High RiskFDA
Raw Seafoods Inc.
Food You Feel Good About Brand, Salmon Teriyaki, Oven Safe
Seafood·762 affected·Mar 13, 2020
High RiskFDA
Raw Seafoods Inc.
Food You Feel Good About, Ginger Salmon, Oven Safe
Seafood·554 affected·Mar 13, 2020
High RiskFDA
Winco Foods Llc
WinCo Foods frozen Blackberries, item # 107414, packaged in polyethylene bags, with a net weight of 16 oz (1 lb or 454g). UPC: 70552 3050...
Produce·2,215 affected·Mar 13, 2020
High RiskFDA
Mcclancy Seasoning Company
Case Label: Rice Dirty Mix Comp 24-17.9 oz bags/case, PACKED EXCLUSIVELY FOR: BR 9432 SOUTHERN PINE BLVD. CHARLOTTE, NC 28273. Bag Label:...
Food·700 affected·Mar 13, 2020
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed...
Oral Drugs·624 affected·Mar 13, 2020
High RiskFDA
Medical Center Pharmacy, Inc.
C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.
Drugs·1 affected·Mar 13, 2020
High RiskFDA
Medical Center Pharmacy, Inc.
*Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 00409-...
Drugs·1 affected·Mar 13, 2020
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed...
Oral Drugs·172,320 affected·Mar 13, 2020
High RiskFDA
Medical Center Pharmacy, Inc.
C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206...
Ophthalmic Drugs·2 affected·Mar 13, 2020
High RiskFDA
Medical Center Pharmacy, Inc.
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 3731...
Drugs·2 affected·Mar 13, 2020
High RiskFDA
Medical Center Pharmacy, Inc.
*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457...
Ophthalmic Drugs·2 affected·Mar 13, 2020
High RiskFDA
Aesthetics Biomedical, Inc.
SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedure...
Surgical Devices·623 affected·Mar 13, 2020
High RiskFDA
Biomet, Inc.
Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in sur...
Medical Devices·125 affected·Mar 13, 2020
CriticalFDA
Chicago Indoor Garden, Inc.
Sprout Salad 6 oz. Product contains red clover sprouts.
Produce·6 affected·Mar 12, 2020
High RiskFDA
Advanced Fresh Concepts Corp
Sushi Ebi Cooked Butterfly Tail-On Whiteleg Shrimp; Tray +0.498 pounds; 20 individual trays per case Distributed by AFC Distribution ...
Dairy·584 affected·Mar 12, 2020
CriticalFDA
Chicago Indoor Garden, Inc.
Mixed Greens 4 oz. Product contains red clover sprouts.
Food·4 affected·Mar 12, 2020
CriticalFDA
Chicago Indoor Garden, Inc.
Spring Salad 6 oz. Product contains red clover sprouts.
Produce·6 affected·Mar 12, 2020
CriticalFDA
Chicago Indoor Garden, Inc.
Red Clover 4 oz, Red Clover 2 Lbs. Products have Red Clover as an ingredient.
Food·2 affected·Mar 12, 2020
High RiskFDA
Greiner Bio-one North America, Inc.
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
Medical Devices·1,000,800 affected·Mar 12, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL ...
Medical Devices·101,463 affected·Mar 12, 2020