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High RiskFDA
Wise Pharmacy
Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Litt...
Injectable Drugs·27 affected·Jul 22, 2019
High RiskFDA
Wise Pharmacy
Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO...
Inhaled / Nasal Drugs·1 affected·Jul 22, 2019
High RiskFDA
Wise Pharmacy
Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Li...
Drugs·1 affected·Jul 22, 2019
High RiskFDA
Wise Pharmacy
Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Injectable Drugs·4 affected·Jul 22, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
Diagnostic Devices·12,796 affected·Jul 22, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
Diagnostic Devices·10,928 affected·Jul 22, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
Diagnostic Devices·3,627 affected·Jul 22, 2019
High RiskFDA
Elevation Foods
Fresket egg salad packaged in 32oz plastic cup with lid, 2 cups per case, refrigerated
Produce·294 affected·Jul 19, 2019
High RiskFDA
Elevation Foods
Fresket Tuna Salad packaged in 5lb plastic container, 2 containers per case, refrigerated
Seafood·13 affected·Jul 19, 2019
High RiskFDA
Elevation Foods
Fresket Thai Lobster Salad packaged in 5lb plastic container, 2 containers per case, refrigerated
Seafood·208 affected·Jul 19, 2019
High RiskFDA
Lupin Pharmaceuticals Inc.
Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. B...
Oral Drugs·11,832 affected·Jul 19, 2019
High RiskFDA
Dercher Enterprises, Inc., Dba Gordon Laboratories
MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon L...
Drugs·277 affected·Jul 19, 2019
High RiskFDA
Ascend Laboratories Llc
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufacture...
Oral Drugs·5,472 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-...
Medical Devices·7,168 affected·Jul 19, 2019
High RiskFDA
Nobel Biocare Usa Llc
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Medical Implants·221 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000...
Medical Devices·19,351 affected·Jul 19, 2019
High RiskFDA
Stryker Corporation
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
Medical Devices·87 affected·Jul 19, 2019
High RiskFDA
Coltene /whaledent Ag
DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
Medical Devices·20 affected·Jul 19, 2019
High RiskFDA
Aniara Diagnostica Llc
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Diagnostic Devices·51 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006...
Medical Devices·473 affected·Jul 19, 2019
High RiskFDA
Philips North America, Llc
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedsi...
Medical Devices·280 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-931...
Medical Devices·502 affected·Jul 19, 2019
High RiskFDA
Stryker Corporation
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
Medical Devices·73 affected·Jul 19, 2019
High RiskFDA
Integra Lifesciences Corp.
Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neur...
Surgical Devices·125 affected·Jul 19, 2019
High RiskFDA
Boston Scientific Corporation
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Medical Devices·1 affected·Jul 19, 2019
High RiskFDA
National Frozen Foods Corporation
Great Value Chopped Spinach, packed in poly bags, net wt. 12 oz. 12 oz. bag UPC: 0 78742 23740 4. master case UPC: 3 00 78742 23740...
Beverages·3,124 affected·Jul 18, 2019
High RiskFDA
Preferred Pharmaceuticals, Inc
Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Generic for: Maxitro...
Topical Drugs·171 affected·Jul 18, 2019
High RiskFDA
Ucb, Inc
Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66.
Oral Drugs·2,088 affected·Jul 18, 2019
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-...
Injectable Drugs·139,680 affected·Jul 18, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Medical Devices·1 affected·Jul 18, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas c513 Analyzer
Medical Devices·2 affected·Jul 18, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 ...
Medical Devices·19 affected·Jul 18, 2019
High RiskFDA
Thermo Fisher Scientific (monterrey)
Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
Medical Devices·514,200 affected·Jul 18, 2019
High RiskFDA
Arrow International Inc
Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Pr...
Surgical Devices·745 affected·Jul 18, 2019
High RiskFDA
Thermo Fisher Scientific (monterrey)
Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904
Medical Devices·2,979,600 affected·Jul 18, 2019
High RiskFDA
Imprimisrx Nj
Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 We...
Ophthalmic Drugs·246 affected·Jul 17, 2019
High RiskFDA
Macleods Pharma Usa Inc
Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 coun...
Oral Drugs·5,448 affected·Jul 17, 2019
High RiskFDA
Imprimisrx Nj
Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledge...
Ophthalmic Drugs·405 affected·Jul 17, 2019
High RiskFDA
Lupin Pharmaceuticals Inc.
Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, In...
Oral Drugs·39,216 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max Enteric Viral Panel RUO; Catalog # 443715
Medical Devices·27 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max StaphSR; Catalog # 443418
Medical Devices·283 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max ExK DNA 1 USA; Catalog # 442817
Medical Devices·115 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit EXT Enteric Bacterial Panel; Catalog # 443812
Medical Devices·715 affected·Jul 17, 2019
High RiskFDA
Owen Mumford Usa, Inc.
Autoject EI, REF AJ1310
Medical Devices·1,510 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max Check-Points CPO IVD EU; Catalog # 278102
Medical Devices·130 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max Enteric Viral Panel EU Catalog # 443985
Medical Devices·469 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max ExK TNA 2; Catalog # 442825
Medical Devices·86 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
Medical Devices·447 affected·Jul 17, 2019