November 14, 2018DrugsFDA
Orexigen Therapeutics, Inc. recalls Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distribute
Hazard: Container packaging defect.
November 14, 2018DrugsFDA
Janssen Pharmaceuticals, Inc. recalls Ortho-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 Regim
Hazard: Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
November 14, 2018DrugsFDA
Janssen Pharmaceuticals, Inc. recalls Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28),
Hazard: Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
November 14, 2018DrugsFDA
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-79
Hazard: Lack of Assurance of Sterility; bags have the potential to leak
November 14, 2018DrugsFDA
ICU Medical Inc recalls 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, I
Hazard: Lack of Assurance of Sterility; bags have the potential to leak
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-17
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Testosterone in Grapeseed Oil 200 mg/mL, a) 4 mL, b) 5 mL, c) 10 mL and d) 30 mL Injectable, Pharm D Solutions, Houston,
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Zinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1418-10
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Water Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- NDC 69699-1407-25
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Vigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions, Houston, Texas --- NDC 69699-135
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1339-05
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65 mg/Phentolamine 0.59 mcg per mL Pharm D Solutions, Houst
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1311-03
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1344-05
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1388-05
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg Powder Pharm D Solutions, Houston, Texas --
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1367
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1366
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1365
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix AT-6 Papa 30 mg/Phent 4 mg/Atrop. 0.3 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1343-05
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous Solution, Pharm D Solutions, Houston, Texa
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per mL Injectable, Pharm D Solutions, Houston,
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texa
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1354-03
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1310-03
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699
Hazard: Lack of Assurance of Sterility
November 7, 2018DrugsFDA
Pharm D Solutions, LLC recalls Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC 69699-1353-10, Pharm D Solutions, H
Hazard: Lack of Assurance of Sterility