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High RiskFDA
Spectrum Laboratory Products
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
Drugs·29 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce...
Injectable Drugs·0 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5...
Topical Drugs·242 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd...
Drugs·246 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 79...
Drugs·11,733 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, B...
Drugs·6,620 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 mL (0.12 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use...
Injectable Drugs·60 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biote...
Injectable Drugs·878 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Us...
Injectable Drugs·708 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL...
Drugs·10,014 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe, Rx Only, KRS Globa...
Drugs·12,445 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Comme...
Drugs·2,565 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Comme...
Injectable Drugs·1,464 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, B...
Injectable Drugs·1,189 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5...
Topical Drugs·1,815 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Bo...
Drugs·2,219 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only KRS Glob...
Injectable Drugs·3,820 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerc...
Injectable Drugs·2,760 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Comme...
Drugs·4,450 affected·Sep 12, 2019
High RiskFDA
Codan Us Corporation
CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on...
Medical Devices·34,776 affected·Sep 12, 2019
High RiskFDA
Stryker Corporation
Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 Th...
Surgical Devices·0 affected·Sep 12, 2019
High RiskFDA
Olympus Corporation Of The Americas
Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of ...
Medical Devices·1,106 affected·Sep 12, 2019
High RiskFDA
Integra Lifesciences Corp.
Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers an...
Medical Devices·189 affected·Sep 12, 2019
High RiskFDA
Merit Medical Systems, Inc.
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introductio...
Medical Devices·15 affected·Sep 12, 2019
High RiskFDA
Lion Foods
Greenland All Natural Gourmet Crispy Fried Onions NET WT 400g UPC 5415685068 packaged in foil bag then carton; Chirag Gourmet Crispy ...
Produce·32,034 affected·Sep 11, 2019
High RiskFDA
Mizuho America, Inc.
Microsurgical Operating Room Tables;7300BX (18-351-70).
Surgical Devices·10 affected·Sep 11, 2019
High RiskFDA
Mizuho America, Inc.
Microsurgical Operating Room Tables;7300B (18-350-70);
Surgical Devices·8 affected·Sep 11, 2019
High RiskFDA
Respironics California, Llc
Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614
Respiratory Devices·2,851 affected·Sep 11, 2019
High RiskFDA
Sonora Mills Foods Inc Dba Popch
Popchips Sour Cream & Onion Potato Popped Chips; 5 oz. bag and 8 oz. bag UPC: 0 82666 50070 4 - 5 oz. 0 82666 77700 7 - 8 oz.
Dairy·6,691 affected·Sep 10, 2019
High RiskFDA
Stark Inc.
Ritter Sport KAFFEESPLITTER Chocolate with caramelized coffee beans; Net Weight: 3.5oz / 100g; Ingredients: sugar, cocoa mass, caramelize...
Dairy·189 affected·Sep 10, 2019
High RiskFDA
Sonora Mills Foods Inc Dba Popch
Popchips Sea Salt Potato Popped Chips; 5 oz. bag, 0.8 oz. bag UPC: 0 82666 50080 3 - 5 oz. ; UPC: 0 82666 71100 1 - 8 oz.
Snacks & Candy·6,691 affected·Sep 10, 2019
High RiskFDA
Sonora Mills Foods Inc Dba Popch
Popchips Variety Pack of Sea Salt, BBQ and Sour Cream and Onion Potato Popped Chips; 8 oz. bag UPC: 0 82666 94002 9
Dairy·6,691 affected·Sep 10, 2019
High RiskFDA
Truong Phu Xanh Co.,
Frozen Yellowfin Tuna, Product of Vietnam, Packaged under the following brands and cuts: Tidal Seafood Tuna Round Steak, size 6 - 8 ...
Meat & Poultry·915,510 affected·Sep 10, 2019
High RiskFDA
Candela Corporation
Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.
Surgical Devices·7,560 affected·Sep 10, 2019
High RiskFDA
Alto Development Corp
A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.
Medical Devices·209 affected·Sep 10, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry...
Diagnostic Devices·1,365,545 affected·Sep 10, 2019
High RiskFDA
Candela Corporation
Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.
Surgical Devices·386 affected·Sep 10, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
Diagnostic Devices·1,365,545 affected·Sep 10, 2019
High RiskFDA
Philips North America Llc
Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
Cardiac Devices·96 affected·Sep 10, 2019
High RiskFDA
Alto Development Corp
A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.
Medical Devices·209 affected·Sep 10, 2019
High RiskFDA
Philips North America Llc
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Cardiac Devices·44 affected·Sep 10, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-...
Diagnostic Devices·1,365,545 affected·Sep 10, 2019
High RiskFDA
Novarad Corporation
NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display im...
Diagnostic Devices·197 affected·Sep 10, 2019
High RiskFDA
Stavis Seafoods, Inc.
MiCal brand YELLOWFIN TUNA POKE CUBE, Raw, Frozen, Product of Vietnam, Wild Caught. Cube size - 1 inch (2cm x 2cm) AAA grade. Product is ...
Seafood·1,330 affected·Sep 9, 2019
High RiskFDA
West-ward Columbus Inc
Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054...
Oral Drugs·32,347 affected·Sep 9, 2019
High RiskFDA
House Of Spices India, Inc.
MDH Sambar Masala; Spices blend for South Indian Cuisine 3.5 oz. (100 g) box. code 6291103750327 Ingredients: coriander, Chili Rec,...
Food·20 affected·Sep 6, 2019
High RiskFDA
Alfa International Seafood Inc
Alfa International Seafood Miami, Fl, 8402, Yellowfin Tuna Loins, Previously Frozen, Wild Caught, Product of Vietnam
Seafood·8,585 affected·Sep 6, 2019
High RiskFDA
Conagra Foods, Inc.
Udi's Classic Hamburger Buns, packaged in a 10.4 oz. plastic bag, with eight bags per wholesale case. UPC 00-6-98997-80913-5 .
Food·2,205 affected·Sep 6, 2019