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.
- 2018-11-14FDA-DrugQualgen, LLCClass IIEstradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count (NDC 69761-006-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
Lack of Assurance of Sterility
- 2018-11-14FDA-DrugQualgen, LLCClass IIEstradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Lack of Assurance of Sterility
- 2018-11-14FDA-DrugQualgen, LLCClass IIEstradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Lack of Assurance of Sterility
- 2018-11-14FDA-DrugQualgen, LLCClass IIEstradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Lack of Assurance of Sterility
- 2018-11-14FDA-DrugQualgen, LLCClass IIEstradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Lack of Assurance of Sterility
- 2018-11-14FDA-DrugQualgen, LLCClass IIEstradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Lack of Assurance of Sterility
- 2018-11-14FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIBEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix, AZ 85085. NDC 42852-001-24
Lack of Assurance of Sterility
- 2018-11-14FDA-DrugTailor Made CompoundingClass IITesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356
Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
- 2018-11-14FDA-DrugBaxter Healthcare CorporationClass IIIMetoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
- 2018-11-14FDA-DrugS.C. Johnson ProfessionalClass IIAlcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441.
CGMP Deviations: Product was released to market prior to microbiological testing.
- 2018-11-14FDA-DrugS.C. Johnson ProfessionalClass IIdeb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27.
CGMP Deviations: Product was released to market prior to microbiological testing.
- 2018-11-14FDA-DrugOrexigen Therapeutics, Inc.Class IIIContrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99
Container packaging defect.
- 2018-11-14FDA-DrugJanssen Pharmaceuticals, Inc.Class IIOrtho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035, 28-Day Regimen per pouch, packaged in a) 6 Veridate Tablet Dispensers and 6 Refill pouches (NDC 504-58-178-28) per carton (NDC 50458-178-06); and b) 12 Veridate Tablet Dispenser Refills (NDC 50458-178-12) per carton (NDC 50458-178-12), Clinic Package, , Rx Only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
- 2018-11-14FDA-DrugJanssen Pharmaceuticals, Inc.Class IIOrtho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560.
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
- 2018-11-14FDA-DrugICU Medical IncClass II0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
Lack of Assurance of Sterility; bags have the potential to leak
- 2018-11-14FDA-DrugICU Medical IncClass II5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
Lack of Assurance of Sterility; bags have the potential to leak
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IITestosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1745-30
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IITestosterone in Grapeseed Oil 200 mg/mL, a) 4 mL, b) 5 mL, c) 10 mL and d) 30 mL Injectable, Pharm D Solutions, Houston, Texas NDC 69699-1702-05
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IIZinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1418-10
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IIWater Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- NDC 69699-1407-25
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IIVigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IITrimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions, Houston, Texas --- NDC 69699-1351-05
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IITrimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1339-05
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IITrimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65 mg/Phentolamine 0.59 mcg per mL Pharm D Solutions, Houston, Texas --- NDC 69699-1366-05
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IITrimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1311-03
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IIPhentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1308-03
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IITrimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1344-05
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IITrimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1388-05
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IITrimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1369-02
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IITrimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1367-02
Lack of Assurance of Sterility
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