Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-02-21FDA-DrugSage Products IncClass IIToothette 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
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IIQCare 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
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IIQCare 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
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IIToothette 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
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IIQ 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
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugSage Products IncClass IIQ.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
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- 2018-02-21FDA-DrugPrimus Pharmaceuticals, Inc.Class ILimbrel500 (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.
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
- 2018-02-21FDA-DrugPrimus Pharmaceuticals, Inc.Class ILimbrel250 (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.
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
- 2018-02-21FDA-DrugPrimus Pharmaceuticals, Inc.Class ILimbrel (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.
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
- 2018-02-21FDA-DrugPrimus Pharmaceuticals, Inc.Class ILimbrel (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.
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
- 2018-02-21FDA-DrugMagno Humphries Laboratories, IncClass ISenna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured for: Basic Drugs, Inc., Vandalia, Ohio 45377, UPC Code 3 07610 22020 1.
Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.
- 2018-02-14FDA-DrugHetero Labs, Ltd. - Unit IIIClass IIAripiprazole 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
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
- 2018-02-14FDA-DrugAstellas Pharma US IncClass IIMycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062, NDC 0469-3211-10
Labeling: Label Error on Declared Strength
- 2018-02-14FDA-DrugTeva Pharmaceuticals USAClass IIIFentanyl 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.
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
- 2018-02-14FDA-DrugTeva Pharmaceuticals USAClass IIIFentanyl 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.
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
- 2018-02-14FDA-DrugTeva Pharmaceuticals USAClass IIIFentanyl 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.
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
- 2018-02-14FDA-DrugTeva Pharmaceuticals USAClass IIIFentanyl 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.
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
- 2018-02-14FDA-DrugMillennium Pharmaceuticals Inc.Class IIVELCADE (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
Defective Container: Confirmed reports of loose vial crimps.
- 2018-02-14FDA-DrugAuroMedics Pharma LLCClass IPantoprazole 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
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
- 2018-02-14FDA-DrugAurobindo Pharma Ltd.Class IAmpicillin 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
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
- 2018-02-14FDA-DrugMckesson Packaging ServicesClass IIIMegestrol 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
Subpotent Drug: Out of specification for assay (stability testing)
- 2018-02-14FDA-DrugAuroMedics Pharma LLCClass ILinezolid 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
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
- 2018-02-14FDA-DrugFlawless Beauty LLCClass IITAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL, Manufactured by: Biomedica Foscama Industria, Ferentino, Italy
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
- 2018-02-14FDA-DrugFlawless Beauty LLCClass IISaluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
- 2018-02-14FDA-DrugFlawless Beauty LLCClass IILing Zhi capsules
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
- 2018-02-14FDA-DrugFlawless Beauty LLCClass IISterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
- 2018-02-14FDA-DrugFlawless Beauty LLCClass IITP Drug Laboratories Vitamin C ampules
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
- 2018-02-14FDA-DrugFlawless Beauty LLCClass IIReiki Glutathione Whitening kits
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
- 2018-02-14FDA-DrugFlawless Beauty LLCClass IILaennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp, Korea
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
- 2018-02-14FDA-DrugFlawless Beauty LLCClass IITationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l.
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
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