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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Toothette Oral Care Suction Swab System With Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Suction Swabs with sodium bicarbonate 0.25 fl oz/7ml Antiseptic Oral Rinse 0.7 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Roarald, Cary, IL 60013. Product Code 6115 Sage Products Inc Class II Terminated 20180221
Toothette Oral Care Short Term Oral Swab System with Antiseptic Oral Rinse, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl oz/44ml bottle of Antiseptic Oral Rinse, .5 oz.14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6100 UPC (01)00618029820969 Sage Products Inc Class II Terminated 20180221
Toothette Oral Care Perox-A- Mint solution, Oral Debriding Agent 8 fl oz/237 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6060 UPC (01)00618029800152 Sage Products Inc Class II Terminated 20180221
Toothette Oral Care Single Use System with Perox-A-Mint solution and Mouth Moisturizer. Contains 2 Toothette Plus Swabs with sodium bicarbonate, .25 fl oz/7ml Perox-A-Mint solution and .07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6013 UPC 6 18029 80008 4 Sage Products Inc Class II Terminated 20180221
Toothette Oral Care Single Use System With Perox-A-Mint solution. Contains: 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml tube of Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6012 UPC (01)00618029800077 Sage Products Inc Class II Terminated 20180221
Toothette Oral Care Daily Oral Cleansing Kit Petite Size with Antiseptic Oral Rinse. Contains: 10 Petite Size Oral Swabs, individually wrapped, 1.5 fl oz/44ml bottle of Antiseptic Oral Rinse, .5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6006 UPC (01)00618029800053 Sage Products Inc Class II Terminated 20180221
Independent Care System Corinz, Contains: 1.5 fl oz bottle Corinz Mouthwash, 0.5 oz/14g tube of Mouth Moisturizer, 0.3 oz/9g tube of Sodium Bicarbonate Mouthpast, 1 Ultra-Soft toothbrush. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6004 UPC 6 18029 82148 5 Sage Products Inc Class II Terminated 20180221
Toothette Oral Care Short Term Oral Care System with Perox-A-Mint solution, Contains 1.5 fl oz/44 ml bottle of Perox-A-Mint solution, 0.5 oz/14g tube of Mouth Moisturizer, 0.3 oz/9g tube of Sodium Bicarbonate Mouthpaste, 1 Ultra-Soft Toothbrush, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6002-D UPC (01)00618029821461 Sage Products Inc Class II Terminated 20180221
Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product code 6000, UPC 6 18029 8001 5 Sage Products Inc Class II Terminated 20180221
Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution. Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, .3 oz./9g tube of Sodium Bicarbonate Mouthpaste, I Ultra-Soft Toothbrush, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6001-D NDC: 53462-024-30 Sage Products Inc Class II Terminated 20180221
Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution. Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, .3 oz./9g tube of Sodium Bicarbonate Mouthpaste, I Ultra-Soft Toothbrush, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6001, UPC (01)00618029800039 Sage Products Inc Class II Terminated 20180221
Toothette Oral Care Antiseptic Oral Rinse 1.5 fl.oz/44 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6122 UPC 6 18029 80079 4 Sage Products Inc Class II Terminated 20180221
Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, 2 Untreated Suctino Toothbrush packages with Antiplaque solution, 4)Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6504. UPC 6 18029 83045 6 Sage Products Inc Class II Terminated 20180221
Toothette Short Term Oral Swab System with Perox-A-Mint Solution. Contains: 20 Individually wrapped Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44mL bottle of Perox-A-Mint solution and One (1) 0.5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6002 UPC (01)00618029820921 Sage Products Inc Class II Terminated 20180221
QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Corinz. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 10 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse and 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6962, UPC 6 18029 83076 0 Sage Products Inc Class II Terminated 20180221
Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Includes 0.25 fl.oz./7mL Perox-A-Mint solution, 0.07oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. NDC: 53462-922-16 Sage Products Inc Class II Terminated 20180221
QCare Rx Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains: 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Perox-A-Mint Solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013 Product Code 6912 UPC 6 18029 83016 6 Sage Products Inc Class II Terminated 20180221
QCare Oral Cleansing and Suctioning System with Corinz. Includes: Two (2) Suction Toothbrush packages with 0.25fl.oz/7mL Corinz Antiseptic Cleansing and Moisturizing Oral Rinse and Four (4) Suction Oral Swab packages with 0.25 fl.oz/7mL Corinze Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6464 UPC 6 18029 83077 7 Sage Products Inc Class II Terminated 20180221
Toothette Oral Care Perox-A-Mint Solution, Oral Debriding Agent, 1.5 fl. oz./44 mL. packet. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6065. UPC 6 18029 80018 3 Sage Products Inc Class II Terminated 20180221
Q Care, Oral Cleansing & Suctioning System Corinz. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Corinz Antiseptic Cleansing & Moisturizing Oral Rinse, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing & Moisturizing Oral Rinse, 2 Oropharyngeal Suction Cather packages. Manufactured by: Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013 Sage Products Inc Class II Terminated 20180221
Q.Care, Oral Cleansing & Suctioning System q4. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages and Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution. Manufactured by: Sage Products, LLC., 3909 Three Oaks Road, Cary, IL 60013 Product Code: 6434; UPC 6 18029 83035 7 Sage Products Inc Class II Terminated 20180221
Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-606-16. Primus Pharmaceuticals, Inc. Class I Terminated 20180221
Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-605-16. Primus Pharmaceuticals, Inc. Class I Terminated 20180221
Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-602-16. Primus Pharmaceuticals, Inc. Class I Terminated 20180221
Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-601-16. Primus Pharmaceuticals, Inc. Class I Terminated 20180221
Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured for: Basic Drugs, Inc., Vandalia, Ohio 45377, UPC Code 3 07610 22020 1. Magno Humphries Laboratories, Inc Class I Terminated 20180221
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30 Hetero Labs, Ltd. - Unit III Class II Terminated 20180214
Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062, NDC 0469-3211-10 Astellas Pharma US Inc Class II Terminated 20180214
Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3214-54. Teva Pharmaceuticals USA Class III Terminated 20180214
Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3213-54. Teva Pharmaceuticals USA Class III Terminated 20180214
Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3212-54. Teva Pharmaceuticals USA Class III Terminated 20180214
Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3198-54. Teva Pharmaceuticals USA Class III Terminated 20180214
VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9% Sodium Chloride to make 2.5 mg/ mL final concentration, INTRAVENOUS INJECTION ONLY add 3.5 mL Sodium Chloride to 1 mg/mL final concentration, Rx Only, Distributed by MILLENNIUM Pharmaceuticals, Inc., Cambridge, MA 02139-4234, NDC 63020-0049-01 Millennium Pharmaceuticals Inc. Class II Terminated 20180214
Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00 AuroMedics Pharma LLC Class I Terminated 20180214
Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20 Aurobindo Pharma Ltd. Class I Terminated 20180214
Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51 Mckesson Packaging Services Class III Terminated 20180214
Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51 AuroMedics Pharma LLC Class I Terminated 20180214
TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL, Manufactured by: Biomedica Foscama Industria, Ferentino, Italy Flawless Beauty LLC Class II Terminated 20180214
Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC Flawless Beauty LLC Class II Terminated 20180214
Ling Zhi capsules Flawless Beauty LLC Class II Terminated 20180214
Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India Flawless Beauty LLC Class II Terminated 20180214
TP Drug Laboratories Vitamin C ampules Flawless Beauty LLC Class II Terminated 20180214
Reiki Glutathione Whitening kits Flawless Beauty LLC Class II Terminated 20180214
Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp, Korea Flawless Beauty LLC Class II Terminated 20180214
Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l. Flawless Beauty LLC Class II Terminated 20180214
Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche Flawless Beauty LLC Class II Terminated 20180214
Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan Flawless Beauty LLC Class II Terminated 20180214
Relumins Vitamin C Solvent ampules Flawless Beauty LLC Class II Terminated 20180214
Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials Flawless Beauty LLC Class II Terminated 20180214
All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583. Intrathecal Compounding Specialist, LLC Class II Terminated 20180214