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CriticalFDA
Procesadora De Dulces Tipicos, S.a. De C.v.
El Super Leon Jabalina Xtreme 50 pieces Net Wt. 2 lb. (3.2 oz.) Cont. Net. 1 kg packaged in a clear plastic jar, 6 jars per case
Food·690 affected·Dec 7, 2018
CriticalFDA
Procesadora De Dulces Tipicos, S.a. De C.v.
1) PICA-BOLA 50 pieces Cont. Net 1 kg Net Wet. 2 lb 3.2 oz., packaged in a clear plastic ja, 6 jars per case and 2) PICA-BOLA 40 pieces ...
Food·686 affected·Dec 7, 2018
High RiskFDA
Us Pharmaceuticals Inc.
Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mu...
Drugs·19,752 affected·Dec 7, 2018
High RiskFDA
Us Pharmaceuticals Inc.
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes...
Topical Drugs·7,020 affected·Dec 7, 2018
RecallFDA
Sun Pharmaceutical Industries, Inc.
Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Res...
Oral Drugs·47,520 affected·Dec 7, 2018
High RiskFDA
Us Pharmaceuticals Inc.
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 6...
Topical Drugs·67,848 affected·Dec 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
Diagnostic Devices·10,414 affected·Dec 7, 2018
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 ...
Medical Implants·11 affected·Dec 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
Diagnostic Devices·1,489 affected·Dec 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
Diagnostic Devices·114 affected·Dec 7, 2018
High RiskFDA
Spectranetics Corporation
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. ...
Surgical Devices·3 affected·Dec 7, 2018
CriticalFDA
Ethicon Endo-surgery Inc
PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessori...
Surgical Devices·15,264 affected·Dec 7, 2018
High RiskFDA
Mariner Seafood, Llc
Salmon packaged in a plastic container; HELLO QUALITY PACIFIC SILVERSIDE SALMON Hello FRESH NET WT. 10oz (283g) with Case Label: keep Fr...
Seafood·1,636 affected·Dec 6, 2018
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, ND...
Oral Drugs·1,996 affected·Dec 6, 2018
High RiskFDA
Vygon U.s.a.
Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
Medical Devices·339,800 affected·Dec 6, 2018
High RiskFDA
Carl Zeiss Meditec, Inc.
VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Las...
Surgical Devices·66 affected·Dec 6, 2018
High RiskFDA
Vygon U.s.a.
Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.
Medical Devices·107,700 affected·Dec 6, 2018
CriticalFDA
Danone Waters Of America Inc
LIGHT & FIT¿ GREEK CRUNCH NONFAT YOGURT & TOPPINGS S MORES FLAVOR, 5 oz Preformed cups with a topper, Refrigeration required between 36F ...
Dairy·3,521 affected·Dec 5, 2018
High RiskFDA
Dr Jackson
DR. JACKSON'S RELAX TEA (ANTI-ANXIETY) 500mL Net Wt 49g; UPC Code: 5 060309 140239. Tea bags are packaged in a glass jar.
Beverages·320 affected·Dec 5, 2018
High RiskFDA
Pharmedium Services, Llc
Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a ...
Injectable Drugs·295 affected·Dec 5, 2018
High RiskFDA
Pharmedium Services, Llc
Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60...
Injectable Drugs·295 affected·Dec 5, 2018
High RiskFDA
Exactech, Inc.
Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals...
Medical Implants·40 affected·Dec 5, 2018
High RiskFDA
Sage Products Inc
Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care co...
Medical Devices·39 affected·Dec 5, 2018
Medium RiskFDA
Medela Inc
Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
Medical Devices·665,600 affected·Dec 5, 2018
High RiskFDA
Beckman Coulter Inc.
UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from t...
Medical Devices·0 affected·Dec 5, 2018
High RiskFDA
Bauer's Candies, Inc.
1 lb QVC combo, 1 lb combo, 2 lb combo, 12 oz combo, 8 oz combo, holiday combo
Food·24 affected·Dec 4, 2018
High RiskFDA
Bauer's Candies, Inc.
Sea Salt Bauer's Candies Modjeskas NET WT 8 oz bag, bulk, 4 oz bag, 1 lb, 2 lb, 8 oz box
Food·21 affected·Dec 4, 2018
High RiskFDA
Bauer's Candies, Inc.
Modjeskas Bauer's Candies NET WT 8 oz, 12 oz, 16 oz, 32 oz. boxes & 4 oz, 8 oz bags, 400 pc case, 216 pc case
Food·97 affected·Dec 4, 2018
High RiskFDA
Earthworks Health
Diatomaceous Earth packaged in the following ways: 1) Perma-Guard, Fossil Shell Flour, Anti-caking agent, Food Chemical Codex Grade, W...
Food·0 affected·Dec 4, 2018
High RiskFDA
Bauer's Candies, Inc.
bulk chocolate bourbon caramels
Snacks & Candy·1 affected·Dec 4, 2018
CriticalFDA
Ellgof Inc.
HomeFresh FOODS Suya Barbecue Seasoning, UPC: 6 033000120298, Net Wt: 240g/0.53 lbs; Produced in Ghana by: ELSSY KESS COMPANY LTD GHANA
Produce·144 affected·Dec 4, 2018
High RiskFDA
Bauer's Candies, Inc.
8 oz assorted modjeska/chocolate modjeskas
Snacks & Candy·1 affected·Dec 4, 2018
High RiskFDA
Bauer's Candies, Inc.
Bauer's Candies Caramels NET WT 4 oz (bag) & bulk, QVC 4 pack caramels
Food·3 affected·Dec 4, 2018
High RiskFDA
Bauer's Candies, Inc.
Bourbon Sea Salt Bauer's Candies Caramels NET WT 4 oz & 8 oz (bag) & bulk
Food·3 affected·Dec 4, 2018
High RiskFDA
Bauer's Candies, Inc.
Bauer's Candies Chocolate Modjeskas NET WT 4 oz & 8 oz bags, 8 oz box, bulk, & 1 lb box
Snacks & Candy·8 affected·Dec 4, 2018
High RiskFDA
Bauer's Candies, Inc.
bulk chocolate caramels
Snacks & Candy·1 affected·Dec 4, 2018
High RiskFDA
Bauer's Candies, Inc.
QVC 40 ct vanilla & dark choc modjeskas
Food·5 affected·Dec 4, 2018
High RiskFDA
Bauer's Candies, Inc.
1 lb salted combo modjeskas
Food·4 affected·Dec 4, 2018
High RiskFDA
Bauer's Candies, Inc.
Bulk assorted
Food·2 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05...
Oral Drugs·32,284 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05...
Oral Drugs·22,813 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-...
Oral Drugs·50,595 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26...
Oral Drugs·129,754 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 265...
Oral Drugs·119,761 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,...
Oral Drugs·76,516 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26...
Oral Drugs·232,180 affected·Dec 4, 2018
High RiskFDA
Epic Pharma, Llc
Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01
Oral Drugs·2,976 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-0...
Oral Drugs·32,696 affected·Dec 4, 2018