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High RiskFDA
The Compounding Shop, Inc.
Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·1 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·80 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·4 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·7 affected·May 2, 2013
High RiskFDA
Hospira Inc.
Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufact...
Injectable Drugs·168,300 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·3 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·78 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·2 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·44 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·1 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Drugs·5 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·55 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·20 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·41 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·2 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·1 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Pete...
Injectable Drugs·14 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·12 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Drugs·1 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·19 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·10 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg...
Injectable Drugs·4 affected·May 2, 2013
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for deliverin...
Surgical Devices·1,465 affected·May 2, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
Medical Devices·445 affected·May 2, 2013
High RiskFDA
Remel Inc
Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Rem...
Diagnostic Devices·109 affected·May 2, 2013
High RiskFDA
Eastland Food Corporation
Asia Best Salted Mackerel, 7 oz. vacuum packages, 25 pkgs/cases; labeled in part ***Eastland Food Corp. 8305 Stayton Drive Jessup, MD 207...
Frozen Food·210 affected·May 1, 2013
High RiskFDA
Medicis Pharmaceutical Corp
CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Dai...
Drugs·2,491 affected·May 1, 2013
High RiskFDA
Applied Medical Resources Corp
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tiss...
Medical Devices·127,305 affected·May 1, 2013
High RiskFDA
Becton Dickinson & Company
BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.
Medical Devices·1,326,000 affected·May 1, 2013
High RiskFDA
Elekta, Inc.
DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometric...
Medical Devices·35 affected·May 1, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC ...
Oral Drugs·77,272 affected·Apr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 6...
Oral Drugs·112,914 affected·Apr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles (NDC ...
Oral Drugs·51,438 affected·Apr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles (NDC 6...
Oral Drugs·51,591 affected·Apr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles (NDC ...
Oral Drugs·107,236 affected·Apr 30, 2013
High RiskFDA
Hospira Inc.
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-234...
Injectable Drugs·44,748 affected·Apr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 6...
Oral Drugs·195,699 affected·Apr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC ...
Oral Drugs·56,405 affected·Apr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles (NDC ...
Oral Drugs·33,227 affected·Apr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 6...
Oral Drugs·194,142 affected·Apr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC ...
Oral Drugs·195,201 affected·Apr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles (NDC ...
Oral Drugs·103,796 affected·Apr 30, 2013
High RiskFDA
Tz Medical Inc.
adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by tr...
Cardiac Devices·10,410 affected·Apr 30, 2013
High RiskFDA
Angiodynamics, Inc.
AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog N...
Medical Devices·1,760 affected·Apr 30, 2013
High RiskFDA
Hill-rom, Inc.
SlingBar 350. Designed to meet the needs for lifting humans.
Medical Devices·3,556 affected·Apr 30, 2013
High RiskFDA
Hill-rom, Inc.
SlingBar Standard. Designed to meet the needs for lifting humans.
Medical Devices·726 affected·Apr 30, 2013
High RiskFDA
Elekta, Inc.
Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conform...
Medical Devices·31 affected·Apr 30, 2013
High RiskFDA
American Optisurgical Inc
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Surgical Devices·63 affected·Apr 30, 2013