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High RiskFDA
Akorn, Inc.
Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, ...
Topical Drugs·142,188 affected·Aug 2, 2021
High RiskFDA
Macleods Pharma Usa Inc
Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactur...
Oral Drugs·444,000 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 ...
Medical Devices·77,802 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopoc...
Medical Devices·24,360 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006
Medical Devices·56,680 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alar...
Medical Devices·344,300 affected·Aug 2, 2021
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, locali...
Medical Devices·1 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
Medical Devices·1,463,647 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
Medical Devices·708,910 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D
Medical Devices·1,839,594 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
Medical Devices·630 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 2002...
Medical Devices·23,786,178 affected·Aug 2, 2021
High RiskFDA
Ge Healthcare, Llc
Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; ...
Medical Devices·310,072 affected·Aug 2, 2021
High RiskFDA
Baycare Integrated Service Center, Llc /dba Baycare Central Pharmacy
Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkw...
Injectable Drugs·253 affected·Jul 30, 2021
High RiskFDA
Custopharm, Inc.
FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92...
Injectable Drugs·19,384 affected·Jul 30, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968...
Topical Drugs·223,382 affected·Jul 30, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0...
Topical Drugs·70,638 affected·Jul 30, 2021
High RiskFDA
Leica Microsystems, Inc.
BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Medical Devices·237 affected·Jul 30, 2021
High RiskFDA
Philips North America Llc
Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-s...
Diagnostic Devices·6 affected·Jul 30, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectio...
Diagnostic Devices·3 affected·Jul 30, 2021
High RiskFDA
Paragon 28, Inc.
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Medical Devices·14 affected·Jul 30, 2021
High RiskFDA
Philips North America Llc
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectio...
Diagnostic Devices·1 affected·Jul 30, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cro...
Diagnostic Devices·2 affected·Jul 30, 2021
High RiskFDA
Philips North America Llc
Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectio...
Diagnostic Devices·3 affected·Jul 30, 2021
High RiskFDA
Full Tilt Ice Cream, Llc
Huckleberry Chip, Full Tilt Ice Cream brand, packaged in 3 gallon tubs. No UPC.
Dairy·50 affected·Jul 29, 2021
High RiskFDA
Full Tilt Ice Cream, Llc
Backyard mint chip, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and and 3 gallon tubs. UPC on pint container: 008569620...
Dairy·500 affected·Jul 29, 2021
High RiskFDA
Full Tilt Ice Cream, Llc
Vanilla Bean, Full Tilt Ice Cream, packaged in 16oz pre packed pints and 3 gallon tubs. UPC on pint containers only: 00856962005283
Dairy·500 affected·Jul 29, 2021
High RiskFDA
Full Tilt Ice Cream, Llc
Coffee Oreo, Full Tilt Ice Cream brand, packaged in 3 gallon tubs. No UPC.
Dairy·100 affected·Jul 29, 2021
High RiskFDA
Full Tilt Ice Cream, Llc
Mexican Chocolate, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3 gallon tubs. UPC on pint container only: 008569620...
Dairy·500 affected·Jul 29, 2021
High RiskFDA
Full Tilt Ice Cream, Llc
Salted Caramel, brand Full Tilt Ice Cream, packaged in 16oz pre-packed pints and 3 gallon tubs. UPC on pint container only: 00856962005009.
Dairy·500 affected·Jul 29, 2021
High RiskFDA
Full Tilt Ice Cream, Llc
Strawberry, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3 gallon tubs. UPC on pint container: 00856962005290.
Dairy·100 affected·Jul 29, 2021
High RiskFDA
Full Tilt Ice Cream, Llc
All The Chocolate, Full Tilt Ice Cream brand, packaged in 3 gallon tubs. No UPC.
Dairy·150 affected·Jul 29, 2021
High RiskFDA
Full Tilt Ice Cream, Llc
Dark Chocolate, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3 gallon tubs. UPC on pint container only: 00856962005...
Dairy·500 affected·Jul 29, 2021
High RiskFDA
Full Tilt Ice Cream, Llc
Thai Tea, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3 gallon tubs. UPC on pint container: 00856962005290.
Dairy·500 affected·Jul 29, 2021
High RiskFDA
Full Tilt Ice Cream, Llc
Ube, Full Tilt Ice Cream brand, packaged in 3 gallon tubs. No UPC.
Dairy·75 affected·Jul 29, 2021
High RiskFDA
Full Tilt Ice Cream, Llc
Peanut Butter Chip, Full Tilt Ice Cream brand, packaged in 3 gallon tubs. No UPC.
Dairy·50 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01
Injectable Drugs·12,698 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, C...
Injectable Drugs·1,351 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, N...
Injectable Drugs·434,229 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Do...
Injectable Drugs·193,845 affected·Jul 29, 2021
High RiskFDA
Pai Holdings, Llc. Dba Pharmaceutical Associates Inc
Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0...
Oral Drugs·75 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva ...
Injectable Drugs·34,100 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort ...
Oral Drugs·4,587 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort...
Oral Drugs·4,992 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-...
Injectable Drugs·16,644 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Do...
Injectable Drugs·50,713 affected·Jul 29, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, ND...
Injectable Drugs·2,091 affected·Jul 29, 2021
High RiskFDA
Sun Pharmaceutical Industries Inc
Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Com...
Oral Drugs·2,856 affected·Jul 29, 2021