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High RiskFDA
New England Life Care, Inc. Dba Advanced Compounding Solutions
SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Wobu...
Drugs·493 affected·Jul 10, 2023
High RiskFDA
Tenn South Distillery Llc Dba Big Machine Distillery
Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machi...
Topical Drugs·540 affected·Jul 10, 2023
High RiskFDA
New England Life Care, Inc. Dba Advanced Compounding Solutions
PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 C...
Injectable Drugs·82 affected·Jul 10, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human ...
Diagnostic Devices·19,544 affected·Jul 10, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (l...
Diagnostic Devices·18,524 affected·Jul 10, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (l...
Diagnostic Devices·50,148 affected·Jul 10, 2023
High RiskFDA
Stryker Corporation
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and reco...
Surgical Devices·57 affected·Jul 10, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lit...
Diagnostic Devices·6,733 affected·Jul 10, 2023
High RiskFDA
Zb Importing Llc
Ziyad Brand Jameed Soup Starter sold in a 35.2 fluid ounce tetra pak container with UPC code 0 74265 00597 1. 12 units per wholesale case
Food·60,109 affected·Jul 7, 2023
High RiskFDA
Sterrx, Llc
Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, R...
Drugs·132,299 affected·Jul 7, 2023
High RiskFDA
Sterrx, Llc
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 uni...
Injectable Drugs·137,304 affected·Jul 7, 2023
High RiskFDA
Sterrx, Llc
Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton...
Drugs·92,148 affected·Jul 7, 2023
High RiskFDA
Sterrx, Llc
Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, R...
Drugs·125,598 affected·Jul 7, 2023
High RiskFDA
Sterrx, Llc
Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case,...
Drugs·2,088 affected·Jul 7, 2023
High RiskFDA
Advance Medical Designs, Inc.
ASG-001; Ultrasound gel
Medical Devices·0 affected·Jul 7, 2023
High RiskFDA
Advance Medical Designs, Inc.
50-GEL20; Ultrasound gel
Medical Devices·13,750 affected·Jul 7, 2023
High RiskFDA
Karl Storz Endoscopy
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Medical Devices·218 affected·Jul 7, 2023
High RiskFDA
Advance Medical Designs, Inc.
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Medical Devices·26,900 affected·Jul 7, 2023
High RiskFDA
Advance Medical Designs, Inc.
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-...
Medical Devices·117,875 affected·Jul 7, 2023
High RiskFDA
Alphatec Spine, Inc.
LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and ...
Medical Devices·29 affected·Jul 7, 2023
High RiskFDA
Advance Medical Designs, Inc.
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 2...
Medical Devices·460 affected·Jul 7, 2023
High RiskFDA
Aquila Corporation
APK2 Pressure-Sensing Wheelchair Cushions
Medical Devices·117 affected·Jul 6, 2023
High RiskFDA
Medtronic Neuromodulation
Medtronic InterStim Ground Pad REF 041826
Medical Devices·360 affected·Jul 6, 2023
High RiskFDA
Teva Pharmaceuticals Usa Inc
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, ND...
Oral Drugs·180 affected·Jul 5, 2023
High RiskFDA
B. Braun Medical Inc.
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5...
Injectable Drugs·79,880 affected·Jul 5, 2023
High RiskFDA
Bellingham Pasta Co
Semolina Shells, net wt. 13oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingh...
Beverages·24 affected·Jul 3, 2023
High RiskFDA
Bellingham Pasta Co
Semolina Spinach Fettuccine, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Craf...
Beverages·38 affected·Jul 3, 2023
High RiskFDA
Bellingham Pasta Co
Semolina Spaghetti, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Belli...
Beverages·81 affected·Jul 3, 2023
High RiskFDA
Bellingham Pasta Co
Semolina Fettuccine, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bell...
Beverages·175 affected·Jul 3, 2023
High RiskFDA
Bellingham Pasta Co
Pasta - Mixed Flavors case. Firm did not provide label.
Food·168 affected·Jul 3, 2023
High RiskFDA
Bellingham Pasta Co
Semolina Gemelli, net wt. 13oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Belling...
Beverages·20 affected·Jul 3, 2023
High RiskFDA
Mondelez Global Llc
belVita Breakfast Sandwich, Dark Chocolate Creme variety (192 - 2 lb 12 oz cartons per pallet)
Snacks & Candy·5,004 affected·Jul 3, 2023
High RiskFDA
Mondelez Global Llc
belVita Breakfast Sandwich, Dark Chocolate Creme variety (6 - 8.8 oz. cartons)
Snacks & Candy·445,264 affected·Jul 3, 2023
High RiskFDA
Mondelez Global Llc
belVita Breakfast Sandwich, Dark Chocolate Creme variety (8 - 14.08 oz packages)
Snacks & Candy·5,581 affected·Jul 3, 2023
High RiskFDA
Bellingham Pasta Co
Semolina Pappardelle, net wt. 13oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bel...
Beverages·199 affected·Jul 3, 2023
High RiskFDA
Bellingham Pasta Co
Semolina Linguine, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellin...
Beverages·78 affected·Jul 3, 2023
High RiskFDA
Bellingham Pasta Co
Semolina Sheets, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingh...
Beverages·3 affected·Jul 3, 2023
High RiskFDA
Mondelez Global Llc
belVita Breakfast Sandwich, Cinnamon Brown Sugar with Vanilla Creme variety (6 - 8.8 oz cartons)
Food·277,593 affected·Jul 3, 2023
High RiskFDA
Bellingham Pasta Co
Semolina Bucatini, net wt. 13oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellin...
Beverages·38 affected·Jul 3, 2023
High RiskFDA
Bellingham Pasta Co
Semolina Roasted Red Pepper Linguine, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & ...
Beverages·24 affected·Jul 3, 2023
High RiskFDA
Bellingham Pasta Co
Semolina Vegan Rigatoni, net wt. 13oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted ...
Beverages·12 affected·Jul 3, 2023
High RiskFDA
Mondelez Global Llc
belVita Breakfast Sandwich, Dark Chocolate Creme variety (8 - 14.08 oz packages)
Snacks & Candy·28,848 affected·Jul 3, 2023
High RiskFDA
Mondelez Global Llc
belVita Breakfast Sandwich, Dark Chocolate Creme variety (6 - 21.12 oz cartons)
Snacks & Candy·90,775 affected·Jul 3, 2023
High RiskFDA
Accord Healthcare, Inc.
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured ...
Injectable Drugs·1,680 affected·Jul 3, 2023
High RiskFDA
Accord Healthcare, Inc.
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare,...
Injectable Drugs·2,348 affected·Jul 3, 2023
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defect...
Medical Devices·24 affected·Jul 3, 2023
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defect...
Medical Devices·24 affected·Jul 3, 2023
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects ...
Medical Devices·14 affected·Jul 3, 2023