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RecallFDA
A-s Medication Solutions Llc.
Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major P...
Oral Drugs·72 affected·Oct 5, 2021
RecallFDA
Primus Corporation Dba Trinity Biotech
A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01...
Diagnostic Devices·340 affected·Oct 5, 2021
High RiskFDA
Akorn, Inc.
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc.,...
Ophthalmic Drugs·10,210 affected·Oct 4, 2021
High RiskFDA
Therakos, Inc.
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Medical Devices·5 affected·Oct 4, 2021
High RiskFDA
Ab Sciex
Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tande...
Medical Devices·30 affected·Oct 4, 2021
RecallFDA
Now Health Group Inc.
NOW Royal Jelly 1500mg 60 VCAPS UPC 733739025654 NOW Royal Jelly 1500mg 60 VCAPS (Distributed by Sofico) UPC 733739150523 Lifesource V...
Supplements·88,890 affected·Oct 1, 2021
RecallFDA
Now Health Group Inc.
NOW Bee Pollen 500mg 100 VCAPS UPC 733739025203
Food·33,056 affected·Oct 1, 2021
RecallFDA
Now Health Group Inc.
NOW Ginseng & Royal Jelly 90 VCAPS UPC 733739040077 MMA Nutrition Ginselin 90 Veg Capsules UPC 733739440075
Food·7,935 affected·Oct 1, 2021
High RiskFDA
Driscoll's Inc.
Driscolls's Fresh Blueberries 6 oz. and 1 pt. clamshell containers Keep refrigerated and rinse before use.
Produce·1,577 affected·Oct 1, 2021
High RiskFDA
Yang Wu International Inc
Asian Pears 5Kg, YW Brand; 14 pears per case
Food·980 affected·Oct 1, 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
High RiskFDA
Bayer Healthcare Pharmaceuticals Inc.
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product ...
Inhaled / Nasal Drugs·738,432 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
High RiskFDA
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, P...
Inhaled / Nasal Drugs·2,817,468 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
High RiskFDA
Bayer Healthcare Pharmaceuticals Inc.
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ...
Inhaled / Nasal Drugs·77,076 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
High RiskFDA
Bayer Healthcare Pharmaceuticals Inc.
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 5...
Inhaled / Nasal Drugs·579,456 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
High RiskFDA
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 07981, P...
Inhaled / Nasal Drugs·4,546,152 affected·Oct 1, 2021
High RiskFDA
Bayer Healthcare Pharmaceuticals Inc.
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dis...
Topical Drugs·579,456 affected·Oct 1, 2021
High RiskFDA
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.
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
High RiskFDA
Bayer Healthcare Pharmaceuticals Inc.
LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 410...
Inhaled / Nasal Drugs·3,816,468 affected·Oct 1, 2021
High RiskFDA
Bayer Healthcare Pharmaceuticals Inc.
Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4...
Inhaled / Nasal Drugs·1,801,332 affected·Oct 1, 2021
High RiskFDA
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
High RiskFDA
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 Ir...
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
High RiskFDA
Cordis Corporation
SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in ...
Medical Implants·26 affected·Oct 1, 2021
High RiskFDA
Limacorporate S.p.a
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
Medical Devices·151 affected·Oct 1, 2021
High RiskFDA
Cordis Corporation
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in ...
Medical Implants·4 affected·Oct 1, 2021
CriticalFDA
Ellume Ltd
Ellume COVID-19 Home Test
Medical Devices·427,994 affected·Oct 1, 2021
High RiskFDA
Cordis Corporation
SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in...
Medical Implants·4 affected·Oct 1, 2021
High RiskFDA
Omnilife Science
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary tota...
Medical Implants·7 affected·Oct 1, 2021
High RiskFDA
Cordis Corporation
SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in th...
Medical Implants·4 affected·Oct 1, 2021
High RiskFDA
Cordis Corporation
SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in th...
Medical Implants·9 affected·Oct 1, 2021
High RiskFDA
Craftmark Bakery, Llc
Chocolate Chip Cookie Dough packaged in 1 case, 6 bags/case, and 30 frozen pies of dough/bag. Labeling reads "Chocolate Chip Cookie Dough...
Bakery & Grains·4,632 affected·Sep 30, 2021
High RiskFDA
Lake Wolf Creamery
Lake Wolf Creamery Queso Oaxaca, ribbon cheese, refrigerated, vacuum packaged in flexible plastic packages, net wt. 3 lbs., 2 lbs., 1.5 l...
Dairy·40 affected·Sep 30, 2021
High RiskFDA
Lake Wolf Creamery
Lake Wolf Creamery Queso Fresco, crumbling fresh cheese, refrigerated, vacuum packaged in flexible plastic packages, net wt. 1.5 lbs. or ...
Dairy·18 affected·Sep 30, 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
High RiskFDA
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·36,660 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
High RiskFDA
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·70,320 affected·Sep 30, 2021
High RiskFDA
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·14,748 affected·Sep 30, 2021