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High RiskFDA
Regency Group, Inc., The
Taco Seasoning Suprema, stock code 03456, packaged in 1 lb., 5 lbs., 25 lbs., or 50 lbs container. The UPC is 0 23605 03456 0
Food·155 affected·Apr 30, 2015
High RiskFDA
Regency Group, Inc., The
Turtle Island Roast Beef Spice Blend, stock code 12690, packaged in 25 lbs.container. No UPC
Meat & Poultry·250 affected·Apr 30, 2015
High RiskFDA
Regency Group, Inc., The
EZ's Burger Deluxe -Burger Blend w/o MSG, stock code 12314, packaged in 50 lbs. container. No UPC.
Food·200 affected·Apr 30, 2015
High RiskFDA
Mission Pharmacal Co
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Mo...
Drugs·2,412 affected·Apr 30, 2015
High RiskFDA
Mission Pharmacal Co
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Su...
Drugs·1,992 affected·Apr 30, 2015
High RiskFDA
Smith & Nephew, Inc.
ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
Medical Devices·202,279 affected·Apr 30, 2015
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Okla...
Oral Drugs·45,022 affected·Apr 29, 2015
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmace...
Oral Drugs·17,533 affected·Apr 29, 2015
High RiskFDA
Janssen Pharmaceuticals, Inc.
Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 bl...
Oral Drugs·16,861 affected·Apr 29, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and pos...
Medical Devices·1,355 affected·Apr 29, 2015
High RiskFDA
Heartware Inc
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refrac...
Cardiac Devices·3,747 affected·Apr 29, 2015
High RiskFDA
Centurion Medical Products Corporation
Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MIN...
Medical Devices·483 affected·Apr 29, 2015
High RiskFDA
Zimmer, Inc.
Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
Surgical Devices·289,616 affected·Apr 29, 2015
High RiskFDA
Richard-allan Scientific Company
Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL Product Usage: A ...
Diagnostic Devices·506 affected·Apr 29, 2015
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct,...
Drugs·50 affected·Apr 28, 2015
High RiskFDA
Fresenius Kabi Usa, Llc
KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufact...
Injectable Drugs·5,488 affected·Apr 28, 2015
High RiskFDA
Alcon Research, Ltd.
The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical profess...
Surgical Devices·219,680 affected·Apr 28, 2015
High RiskFDA
Covidien Llc
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Medical Devices·1,661 affected·Apr 28, 2015
High RiskFDA
Fresenius Medical Care Holdings, Inc.
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Medical Devices·22,640,288 affected·Apr 27, 2015
High RiskFDA
Boston Scientific Corporation
Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extra...
Surgical Devices·39 affected·Apr 27, 2015
High RiskFDA
Sheffield Pharmaceuticals, Llc
Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
Medical Devices·37,636 affected·Apr 27, 2015
High RiskFDA
Romark Laboratories, L.c.
Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimor...
Oral Drugs·32,893 affected·Apr 24, 2015
High RiskFDA
Ge Healthcare
D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 mon...
Respiratory Devices·5,018 affected·Apr 24, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with ...
Medical Devices·1,420 affected·Apr 24, 2015
High RiskFDA
Greystone Foods Llc
Today's Harvest(TM) Broccoli Florets, GRADE A SELECT, NET WT. 2 LBS., (907 g), KEEP FROZEN, packed by Greystone Foods, LLC, Birmingham, A...
Frozen Food·1,692 affected·Apr 23, 2015
High RiskFDA
Alpine Bistro & Bakery Company
7 -Layer Bar, 7-ounce(200 gram) flexible plastic wrap with adhesive-backed label.
Food·209 affected·Apr 23, 2015
High RiskFDA
Greystone Foods Llc
Today's Harvest(TM) Field Peas w/Snaps, GRADE A SELECT, NET WT. 2 LBS., (907 g), KEEP FROZEN, packed by Greystone Foods, LLC, Birmingham,...
Frozen Food·11,004 affected·Apr 23, 2015
High RiskFDA
Greystone Foods Llc
Today's Harvest(TM) Silver Queen style Corn, GRADE A SELECT, NET WT. 2 LBS., (907 g), KEEP FROZEN, packed by Greystone Foods, LLC, Birmin...
Frozen Food·2,370 affected·Apr 23, 2015
High RiskFDA
Roxy Trading Inc
Seasoning Fish Filet Ingredients: Mixed Fish, Sugar, Salt, Monosodium Glutamate, Sorbic Acid Bulk cases with 12kg of fish fillets w...
Seafood·148 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA
Drugs·24 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
Oral Drugs·540 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
Oral Drugs·0 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Topical Drugs·36 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA -non-sterile formulation
Oral Drugs·40 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Co...
Injectable Drugs·337 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
Injectable Drugs·335 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Topical Drugs·211 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA
Oral Drugs·2,355 affected·Apr 23, 2015
High RiskFDA
Remedyrepack Inc.
KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA...
Drugs·25 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA
Injectable Drugs·172 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Topical Drugs·61 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA
Drugs·5 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA
Oral Drugs·2,380 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
Oral Drugs·2,370 affected·Apr 23, 2015
High RiskFDA
South Coast Specialty Compounding, Inc.
Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Topical Drugs·24 affected·Apr 23, 2015
High RiskFDA
Covidien Llc
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458P
Surgical Devices·72,363 affected·Apr 23, 2015
High RiskFDA
Covidien Llc
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063P
Surgical Devices·72,363 affected·Apr 23, 2015
High RiskFDA
Covidien Llc
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049CP
Surgical Devices·72,363 affected·Apr 23, 2015