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Medium RiskFDA
Legacy Pharmaceutical Packaging Llc
Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick...
Oral Drugs·111,948 affected·Sep 24, 2020
Medium RiskFDA
Ultra Seal Corporation
Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenie...
Oral Drugs·701,735 affected·Aug 3, 2020
Medium RiskFDA
Vistapharm, Inc.
Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-...
Oral Drugs·380,700 affected·Jun 23, 2020
Medium RiskFDA
Somerset Therapeutics Llc
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Mad...
Drugs·383,437 affected·Jun 4, 2020
Medium RiskFDA
Pfizer Inc.
Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx On...
Oral Drugs·544,400 affected·May 27, 2020
Medium RiskFDA
Unichem Pharmaceuticals Usa Inc
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, P...
Oral Drugs·190,992 affected·May 26, 2020
Medium RiskFDA
Golden State Medical Supply Inc.
TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufac...
Oral Drugs·379,043 affected·Feb 12, 2020
Medium RiskFDA
Auromedics Pharma Llc
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Phar...
Topical Drugs·100,080 affected·Dec 2, 2019
Medium RiskFDA
Auromedics Pharma Llc
Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Phar...
Injectable Drugs·138,720 affected·Nov 11, 2019
Medium RiskFDA
Sandoz Inc
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laborator...
Ophthalmic Drugs·346,929 affected·Oct 17, 2019
Medium RiskFDA
Sandoz Inc
Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b)...
Topical Drugs·346,929 affected·Oct 17, 2019
Medium RiskFDA
Sato Pharmaceutical Inc.
Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Sui...
Oral Drugs·210,744 affected·Oct 1, 2019
Medium RiskFDA
Sato Pharmaceutical Inc.
WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (NDC 0363-1407-01, UPC 3 11917-18328 2 ) and b) 18-count boxe...
Oral Drugs·112,104 affected·Oct 1, 2019
Medium RiskFDA
Frito-lay, Inc.
Tostitos Medium Queso Blanco Dip 23 oz. packaged in clear glass jar UPC 28400 66872
Food·217,004 affected·Aug 28, 2019
Medium RiskFDA
Bausch & Lomb
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals Nort...
Topical Drugs·170,832 affected·Jun 17, 2019
Medium RiskFDA
Tate & Lyle Ingredients Americas, Llc
Food starch, brand names Miraqk Mgl and Nustar 120 and Nustar 140
Food·128,850 affected·Jun 10, 2019
Medium RiskFDA
Pfizer Inc.
Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40...
Oral Drugs·100,277 affected·Apr 29, 2019
Medium RiskFDA
Advantice Health
Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma...
Inhaled / Nasal Drugs·111,492 affected·Apr 25, 2019
Medium RiskFDA
Advantice Health
Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only; Distributed by Mo...
Inhaled / Nasal Drugs·111,492 affected·Apr 25, 2019
Medium RiskFDA
Ningbo Huize Commodity Co.,ltd.
Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China.
Drugs·126,500 affected·Apr 1, 2019
Medium RiskFDA
Lupin Pharmaceuticals Inc.
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68...
Ophthalmic Drugs·674,628 affected·Feb 26, 2019
Medium RiskFDA
Medela Inc
Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
Medical Devices·665,600 affected·Dec 5, 2018
Medium RiskFDA
Baxter Healthcare Corporation
Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifes...
Injectable Drugs·402,165 affected·Oct 15, 2018
Medium RiskFDA
Baxter Healthcare Corporation
Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 360...
Injectable Drugs·523,896 affected·Sep 25, 2018
Medium RiskFDA
Baxter Healthcare Corporation
Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactur...
Injectable Drugs·191,256 affected·Aug 1, 2018
Medium RiskFDA
Baxter Healthcare Corporation
Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufact...
Injectable Drugs·711,216 affected·Aug 1, 2018
Medium RiskFDA
Baxter Healthcare Corporation
Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufact...
Injectable Drugs·106,320 affected·Aug 1, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Product...
Diagnostic Devices·128,196 affected·Jul 11, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitr...
Diagnostic Devices·627,543 affected·Jul 11, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products ...
Diagnostic Devices·420,105 affected·Jul 11, 2018
Medium RiskFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Onl...
Oral Drugs·130,081 affected·Jun 12, 2018
Medium RiskFDA
Pharmaceutical Associates Inc
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates...
Oral Drugs·275,400 affected·May 29, 2018
Medium RiskFDA
Akorn, Inc.
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (ND...
Oral Drugs·561,800 affected·Mar 29, 2018
Medium RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, ...
Oral Drugs·109,080 affected·Mar 19, 2018
Medium RiskFDA
Alva-amco Pharmacal Companies., Inc.
Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharm...
Topical Drugs·206,513 affected·Mar 9, 2018
Medium RiskFDA
Novel Laboratories, Inc.
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, ...
Oral Drugs·134,364 affected·Mar 5, 2018
Medium RiskFDA
Teva Pharmaceuticals Usa
Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laborato...
Drugs·929,916 affected·Jan 29, 2018
Medium RiskFDA
G & W Laboratories, Inc.
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (N...
Topical Drugs·142,236 affected·Jan 19, 2018
Medium RiskFDA
Perkinelmer Health Sciences, Inc.
PerkinElmer 226 Sample Collection Device
Medical Devices·164,952 affected·Dec 19, 2017
Medium RiskFDA
Lupin Pharmaceuticals Inc.
Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryl...
Oral Drugs·111,648 affected·Nov 21, 2017
Medium RiskFDA
Bayer Healthcare Pharmaceuticals, Inc.
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 0796...
Oral Drugs·104,128 affected·Nov 10, 2017
Medium RiskFDA
Allergan Sales, Llc
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL ...
Ophthalmic Drugs·715,041 affected·Oct 19, 2017
Medium RiskFDA
Allergan Sales, Llc
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
Ophthalmic Drugs·153,616 affected·Oct 19, 2017
Medium RiskFDA
Dr. Reddy's Laboratories, Inc.
Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by...
Oral Drugs·569,376 affected·Oct 3, 2017
Medium RiskFDA
Vi-jon, Inc.
Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in 10 fl. oz. (296 mL) bottles, Labeled as a) CVS Health, Distr...
Oral Drugs·348,384 affected·Sep 13, 2017
Medium RiskFDA
Teva Pharmaceuticals Usa
Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per ...
Drugs·401,750 affected·Jul 25, 2017
Medium RiskFDA
Akorn Inc
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19)...
Oral Drugs·541,900 affected·Jul 12, 2017
Medium RiskFDA
Akorn Inc
Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Heal...
Oral Drugs·101,952 affected·Jul 12, 2017