September 26, 2018DrugsFDA
QuVa Pharma, Inc. recalls Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173,
Hazard: Subpotent Drug: Product may not have the active ingredient present in the bag.
September 19, 2018DrugsFDA
Accord Healthcare, Inc. recalls Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham,
Hazard: Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
September 19, 2018DrugsFDA
Hellolife recalls Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapi
Hazard: Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
September 19, 2018DrugsFDA
Hellolife recalls Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapi
Hazard: Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
September 19, 2018DrugsFDA
Hellolife recalls Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapi
Hazard: Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
September 19, 2018DrugsFDA
Hellolife recalls Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapi
Hazard: Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
September 19, 2018DrugsFDA
SCA Pharmaceuticals, Inc. recalls Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmac
Hazard: Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
September 19, 2018DrugsFDA
United Therapeutics Corp. recalls Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.
Hazard: Defective Delivery System: Water ingress through the lower water cup sensor of the device.
September 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV
Hazard: Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
September 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV
Hazard: Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
September 19, 2018DrugsFDA
Par Pharmaceutical, Inc. recalls Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: P
Hazard: Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
September 19, 2018DrugsFDA
Pfizer Inc. recalls Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, In
Hazard: Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
September 12, 2018DrugsFDA
Akorn, Inc. recalls Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 3006
Hazard: Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
September 12, 2018DrugsFDA
Avkare Incorporated recalls AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. P
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 12, 2018DrugsFDA
Avkare Incorporated recalls AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 12, 2018DrugsFDA
Avkare Incorporated recalls AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc.
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 12, 2018DrugsFDA
Avkare Incorporated recalls AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 12, 2018DrugsFDA
Avkare Incorporated recalls AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc.
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 12, 2018DrugsFDA
Mckesson Corporation recalls Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharm
Hazard: Supterpotent Drug
September 5, 2018DrugsFDA
Validus Pharmaceuticals, Inc. recalls Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Pars
Hazard: Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
September 5, 2018DrugsFDA
Validus Pharmaceuticals, Inc. recalls Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL
Hazard: Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
September 5, 2018DrugsFDA
Pfizer Global Supply recalls Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 0794
Hazard: Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
September 5, 2018DrugsFDA
Akorn, Inc. recalls Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn,
Hazard: Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
September 5, 2018DrugsFDA
Auro Pharmacies, Inc. recalls Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La
Hazard: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
September 5, 2018DrugsFDA
Auro Pharmacies, Inc. recalls Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra
Hazard: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
September 5, 2018DrugsFDA
Auro Pharmacies, Inc. recalls Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only,
Hazard: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
September 5, 2018DrugsFDA
Auro Pharmacies, Inc. recalls Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Ce
Hazard: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
September 5, 2018DrugsFDA
Auro Pharmacies, Inc. recalls Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only,
Hazard: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
September 5, 2018DrugsFDA
Auro Pharmacies, Inc. recalls Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La
Hazard: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
September 5, 2018DrugsFDA
Auro Pharmacies, Inc. recalls Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La H
Hazard: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.