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CriticalFDA
Onions 52
12 count per 2 lb. mesh sacks with UPC 033383 601014 Medium Red Onions Product of Mexico Farm Fresh Label Distributed by Onions 52 Carrol...
Produce·97 affected·Oct 21, 2021
CriticalFDA
Philips North America Llc
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Diagnostic Devices·512 affected·Oct 21, 2021
CriticalFDA
Philips North America Llc
ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
Diagnostic Devices·243 affected·Oct 21, 2021
CriticalFDA
Prosource Produce Llc
Whole raw YELLOW onions are imported from Chihuahua of MEXICO. Products are packaged in 50 lb., 25 lb., 10 lb., 5 lb., 3 lb., and 2 lb....
Produce·26,628,274 affected·Oct 20, 2021
CriticalFDA
Prosource Produce Llc
Whole raw RED onions are imported from Chihuahua of MEXICO. Products are packaged in 50 lb., 25 lb., 10 lb., 5 lb., 3 lb., and 2 lb. me...
Produce·6,820,172 affected·Oct 20, 2021
CriticalFDA
Prosource Produce Llc
Whole raw WHITE onions are imported from Chihuahua of MEXICO. Products are packaged in 50 lb., 25 lb., 10 lb., 5 lb., 3 lb., and 2 lb. ...
Produce·2,539,656 affected·Oct 20, 2021
CriticalFDA
Lakeview Farms, Llc.
Smilin' Bob's Key West Original Smoked Fish Dip 8oz plastic container with tamper proof lid 12 containers per case
Seafood·5,532 affected·Oct 20, 2021
CriticalFDA
Merck Sharp & Dohme Corp
Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Me...
Injectable Drugs·76,163 affected·Oct 19, 2021
CriticalFDA
Lumenis, Inc.
IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel ...
Medical Devices·11,064 affected·Oct 14, 2021
CriticalFDA
Teligent Pharma, Inc.
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 525...
Topical Drugs·52,104 affected·Oct 12, 2021
CriticalFDA
Bryant Ranch Prepack, Inc. Dba Brp Pharmaceuticals
Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) b...
Oral Drugs·124 affected·Oct 12, 2021
CriticalFDA
Forbes Rehab Services Inc
Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for...
Medical Devices·3,065 affected·Oct 11, 2021
CriticalFDA
Cook Inc.
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal ...
Surgical Devices·4,789 affected·Oct 8, 2021
CriticalFDA
Cook Inc.
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
Medical Devices·31,502 affected·Oct 8, 2021
CriticalFDA
Nestle Usa Inc
Nature's Heart Superfood Trail Mix 1.5oz poly film pouches - 32 units per case
Food·1,149 affected·Oct 7, 2021
CriticalFDA
Nestle Usa Inc
Nature's Heart Mango Turmeric Cashew Glazed Mix 1.5oz poly film pouches - 32 units per case
Food·1,102 affected·Oct 7, 2021
CriticalFDA
Northeast Seafood Products, Incorporated
Haddock, Monkfish, Bone-in Trout, Grouper, Red Snapper, Red Rock Cod, Ocean Perch, Pacific Cod, Halibut, Coho Salmon, Atlantic Salmon Por...
Seafood·6,416 affected·Oct 7, 2021
CriticalFDA
Nestle Usa Inc
Nature's Heart Pineapple Chili Cashew Glazed Mix 1.5oz poly film pouches - 32 units per case
Food·930 affected·Oct 7, 2021
CriticalFDA
Nestle Usa Inc
Nature's Heart Toasted Coconut Chips 1.5oz poly film pouches - 32 units per case
Snacks & Candy·1,055 affected·Oct 7, 2021
CriticalFDA
Kwokcheng Enterprise, Inc. Dba Fullei Fresh
All products are stored refrigerated and labeled with Fullei Fresh brand. 10 lb Bean Sprouts in cardboard box; 5 lb Bean Sprouts in card...
Food·9,438 affected·Oct 5, 2021
CriticalFDA
Bayer Healthcare Pharmaceuticals Inc.
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 200061...
Inhaled / Nasal Drugs·2,841,012 affected·Oct 1, 2021
CriticalFDA
Bayer Healthcare Pharmaceuticals Inc.
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 870228...
Inhaled / Nasal Drugs·4,990,860 affected·Oct 1, 2021
CriticalFDA
Bayer Healthcare Pharmaceuticals Inc.
LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 0798...
Inhaled / Nasal Drugs·4,546,152 affected·Oct 1, 2021
CriticalFDA
Bayer Healthcare Pharmaceuticals Inc.
Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, N...
Inhaled / Nasal Drugs·579,456 affected·Oct 1, 2021
CriticalFDA
Bayer Healthcare Pharmaceuticals Inc.
LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, ...
Inhaled / Nasal Drugs·2,817,468 affected·Oct 1, 2021
CriticalFDA
Bayer Healthcare Pharmaceuticals Inc.
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 ...
Inhaled / Nasal Drugs·738,432 affected·Oct 1, 2021
CriticalFDA
Bayer Healthcare Pharmaceuticals Inc.
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Fi...
Inhaled / Nasal Drugs·592,416 affected·Oct 1, 2021
CriticalFDA
Bayer Healthcare Pharmaceuticals Inc.
LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product ...
Inhaled / Nasal Drugs·3,816,468 affected·Oct 1, 2021
CriticalFDA
Ellume Ltd
Ellume COVID-19 Home Test
Medical Devices·427,994 affected·Oct 1, 2021
CriticalFDA
Best Foods Nj, Inc.
Sundelight Golden Raisins Net Wt 7oz. UPC: 14760 84059. Plastic pouches. 20 pouches/per case
Food·3 affected·Sep 30, 2021
CriticalFDA
Beiersdorf Inc
Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 U...
Inhaled / Nasal Drugs·142,236 affected·Sep 30, 2021
CriticalFDA
Beiersdorf Inc
Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 068...
Inhaled / Nasal Drugs·167,808 affected·Sep 30, 2021
CriticalFDA
Beiersdorf Inc
Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can,...
Inhaled / Nasal Drugs·143,376 affected·Sep 30, 2021
CriticalFDA
Beiersdorf Inc
Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 068...
Inhaled / Nasal Drugs·124,668 affected·Sep 30, 2021
CriticalFDA
Beiersdorf Inc
Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 U...
Inhaled / Nasal Drugs·38,328 affected·Sep 30, 2021
CriticalFDA
B&g Foods North America, Inc
Tone s Taco Seasoning Blend, Plastic Bottles / 12 bottles per case with best by dates of SEPT 03 24 and SEPT 06 24, due to the
Food·3,867 affected·Sep 29, 2021
CriticalFDA
Cuisine Innovations Unlimited, Llc
Vemondo Vegan Crabless Mini Crabcakes by Lidl 8.5 OUNCES (240g) coated paper box ten (10) packages per case. Frozen.
Seafood·1,800 affected·Sep 24, 2021
CriticalFDA
Eli Lilly & Company
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed ...
Injectable Drugs·19,174 affected·Sep 24, 2021
CriticalFDA
Whole Foods Market Brand 365, Llc
Whole Foods Market Everyday Double Crust Apple Pie sold in clear plastic clamshell with scale label applied. Sold as whole pie or by the ...
Food·548 affected·Sep 22, 2021
CriticalFDA
Whole Foods Market Brand 365, Llc
Whole Foods Market Everyday Double Crust Cherry Pie sold in clear plastic clamshell with scale label applied. Sold as whole pie or by the...
Food·548 affected·Sep 22, 2021
CriticalFDA
Medtech Sas
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guide...
Surgical Devices·119 affected·Sep 22, 2021
CriticalFDA
Datascope Corp.
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the belo...
Medical Devices·131 affected·Sep 21, 2021
CriticalFDA
Litehouse Inc
Litehouse item 15533 Ranch dressing packaged in 1.25 oz. plastic cup with seal, 336 cups per case. It is printed on the side of a plastic...
Food·1,063 affected·Sep 20, 2021
CriticalFDA
Arrow International Inc
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous ...
Surgical Devices·1,167 affected·Sep 20, 2021
CriticalFDA
Arrow International Inc
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous...
Surgical Devices·1,918 affected·Sep 20, 2021
CriticalFDA
The Earl Of Sandwiches
Earle of Sandwiches Mild Smoked Jalapeno Sub, Smoked Jalapeno Sausage and Peperjack Cheese on Parmasan Crusted French Bread. Net Wt. 7oz...
Dairy·2,776 affected·Sep 16, 2021
CriticalFDA
The Earl Of Sandwiches
Duke of Earle Spicy Chicken Sub, Seasoned Chicken with Pepper Jack Cheese on Garlic Pepper French Bread. Net Wt. 7oz (198g), UPC 97256 1...
Dairy·180 affected·Sep 16, 2021
CriticalFDA
The Earl Of Sandwiches
Earle of Sandwiches X-Large Roast Beef Italiano, Italian Roast Beef & Swiss Cheese on Garlic Pepper French Bread. Net Wt. 10.25 oz (297g...
Dairy·2,040 affected·Sep 16, 2021