August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only,
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manu
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Ma
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manuf
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Man
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufacture
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
MAJOR PHARMACEUTICALS recalls Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Li
Hazard: Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
August 1, 2018DrugsFDA
MAJOR PHARMACEUTICALS recalls Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt
Hazard: Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
August 1, 2018DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, I
Hazard: Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufacture
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactur
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactu
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactur
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceuti
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai Pharmaceu
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceuti
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceu
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
MAJOR PHARMACEUTICALS recalls Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
MAJOR PHARMACEUTICALS recalls Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
July 25, 2018DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. Fo
Hazard: Lack of Assurance of Sterility: Potential leakage of bags.
July 25, 2018DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose
Hazard: Lack of Assurance of Sterility: Potential leakage of bags.
July 25, 2018DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9
Hazard: Lack of Assurance of Sterility: Potential leakage of bags.
July 25, 2018DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vida
Hazard: Lack of Assurance of Sterility: Potential leakage of bags.
July 25, 2018DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL Single
Hazard: Lack of Assurance of Sterility: Potential leakage of bags.
July 25, 2018DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL)
Hazard: Lack of Assurance of Sterility: Potential leakage of bags.
July 25, 2018DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston,
Hazard: Lack of Assurance of Sterility: Potential leakage of bags.
July 25, 2018DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag
Hazard: Lack of Assurance of Sterility: Potential leakage of bags.
July 25, 2018DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL) Volume: 55mL. Single dose syringe.
Hazard: Lack of Assurance of Sterility: Potential leakage of bags.
July 25, 2018DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Fo
Hazard: Lack of Assurance of Sterility: Potential leakage of bags.