August 22, 2018DrugsFDA
Northwind Pharmaceuticals LLC recalls Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 4
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 22, 2018DrugsFDA
Northwind Pharmaceuticals LLC recalls Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laborat
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection, 18mcg/1.8 mg/0.2 mg/0.02 mg/mL, 1
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vial, Rx only, Ranier's Rx Laboratory, 11
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A,
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue S
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette,
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vial
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Ranier's Compounding Laboratory recalls Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA
Hazard: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
August 22, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 5
Hazard: Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
August 22, 2018DrugsFDA
The Hain Celestial Group, Inc. - Worldwide HQ recalls alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celes
Hazard: Microbial Contamination of a Non-Sterile Product
August 22, 2018DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryl
Hazard: Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
August 22, 2018DrugsFDA
Huijing (Shanghai) Bio-tech Co., Ltd. recalls Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc.
Hazard: Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
August 15, 2018DrugsFDA
World Organix, LLC recalls Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged in While Foil Pouch. Dist. by World Organ
Hazard: Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
August 15, 2018DrugsFDA
World Organix, LLC recalls Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in While Foil Pouch, Dist. by World Organix LLC,
Hazard: Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
August 15, 2018DrugsFDA
World Organix, LLC recalls Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle. Distributed by World Organix LLC Las Vegas
Hazard: Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
August 15, 2018DrugsFDA
World Organix, LLC recalls Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml) UPC#6 02401 88900 3.
Hazard: Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
August 15, 2018DrugsFDA
World Organix, LLC recalls Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Org
Hazard: Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
August 15, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23
Hazard: Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
August 15, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High
Hazard: API material used in the manufacturing of the product did not receive regulatory approval prior to release.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. St
Hazard: Lack of sterility assurance.