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High RiskFDA
Randox Laboratories Ltd.
Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in...
Medical Devices·18 affected·Aug 2, 2016
High RiskFDA
Best Sanitizers Inc
Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set ...
Medical Devices·3,023 affected·Aug 2, 2016
High RiskFDA
Odyssey Enterprises Inc
Split Cooked King Crab Leg & Claw, repacked by Odyssey, net wt. 20 lbs. per box, keep frozen. UPC 28575 96323 The label is read in p...
Seafood·400 affected·Aug 1, 2016
High RiskFDA
Isomeric Pharmacy Solution, Llc
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isom...
Injectable Drugs·2,331 affected·Aug 1, 2016
High RiskFDA
Spectrum Laboratory Products, Inc.
Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901
Drugs·14,000 affected·Aug 1, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, an...
Medical Devices·37 affected·Aug 1, 2016
High RiskFDA
Aesculap Implant Systems Llc
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Medical Devices·180 affected·Aug 1, 2016
High RiskFDA
Ethicon, Inc.
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
Medical Devices·396,024 affected·Aug 1, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembl...
Medical Implants·2,039 affected·Aug 1, 2016
High RiskFDA
Drews Llc
SimplyNature Organic Chipotle Ranch Dressing, Net Wt. 12 FL OZ (354mL), UPC: 0 41498 21862 1
Snacks & Candy·2,011 affected·Jul 29, 2016
High RiskFDA
Sage Products Llc
2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #97...
Drugs·2,756 affected·Jul 29, 2016
High RiskFDA
Teva Pharmaceuticals Usa
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wale...
Injectable Drugs·27,547 affected·Jul 29, 2016
High RiskFDA
Sage Products Llc
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into ...
Topical Drugs·616,561 affected·Jul 29, 2016
High RiskFDA
Teva Pharmaceuticals Usa
Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales,...
Injectable Drugs·11,844 affected·Jul 29, 2016
High RiskFDA
Zimmer Biomet, Inc.
ROSA BRAIN 3.0.0
Medical Devices·2 affected·Jul 29, 2016
High RiskFDA
B. Braun Medical, Inc.
Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
Medical Devices·15,950 affected·Jul 29, 2016
High RiskFDA
Zyno Medical Llc
Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Produ...
Surgical Devices·114,081 affected·Jul 29, 2016
High RiskFDA
Zyno Medical Llc
Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product ...
Surgical Devices·47,989 affected·Jul 29, 2016
High RiskFDA
Zyno Medical Llc
Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Produc...
Surgical Devices·78,063 affected·Jul 29, 2016
High RiskFDA
Colonia Care Pharmacy
C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Drugs·0 affected·Jul 28, 2016
High RiskFDA
Colonia Care Pharmacy
C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Drugs·0 affected·Jul 28, 2016
High RiskFDA
Handicare Ab
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Medical Devices·9 affected·Jul 28, 2016
High RiskFDA
Hospira Inc., A Pfizer Company
Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the Sapph...
Medical Devices·20 affected·Jul 28, 2016
High RiskFDA
Orthopediatrics Corp
3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantag...
Medical Devices·41 affected·Jul 27, 2016
High RiskFDA
Orthopediatrics Corp
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantag...
Medical Devices·41 affected·Jul 27, 2016
High RiskFDA
La Torre Foods Usa, Inc.
la Torre Copito Marshmallow Chocolate Cookie NET WT 4.94 oz packaged in a cardboard box.
Bakery & Grains·16,262 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·23 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·36 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Drugs·139 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compounder, Hattiesburg, MS
Injectable Drugs·5 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tet...
Drugs·6 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Injectable Drugs·1 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain...
Injectable Drugs·1 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·8 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·62 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·108 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·14 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5....
Injectable Drugs·1 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67...
Ophthalmic Drugs·6 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg, MS
Drugs·6 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·6 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compou...
Injectable Drugs·3 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/ml, Dexamethasone Sodium Phosphate 1mg/ml, Rx only, For oph...
Ophthalmic Drugs·1 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesb...
Drugs·386,606 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS
Ophthalmic Drugs·0 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Drugs·16 affected·Jul 26, 2016
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Injectable Drugs·1 affected·Jul 26, 2016
High RiskFDA
Howmedica Osteonics Corp.
AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion wit...
Medical Devices·0 affected·Jul 26, 2016