April 3, 2019DrugsFDA
Ecolab Inc recalls Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-488-49) and b) 540
Hazard: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
April 3, 2019DrugsFDA
Ecolab Inc recalls Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl
Hazard: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
April 3, 2019DrugsFDA
Ingenus Pharmaceuticals Llc recalls Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceutic
Hazard: Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
April 3, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and eth
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
April 3, 2019DrugsFDA
Allergan Sales, LLC recalls Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irv
Hazard: cGMP Deviations
March 27, 2019DrugsFDA
Heritage Pharmaceuticals, Inc. recalls Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals
Hazard: Subpotent Drug.
March 27, 2019DrugsFDA
Rising Pharmaceuticals, Inc. recalls Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactur
Hazard: CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
March 27, 2019DrugsFDA
Rising Pharmaceuticals, Inc. recalls Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, M
Hazard: CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
March 27, 2019DrugsFDA
Rising Pharmaceuticals, Inc. recalls Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, M
Hazard: CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
March 27, 2019DrugsFDA
Rising Pharmaceuticals, Inc. recalls Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufa
Hazard: CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
March 27, 2019DrugsFDA
Preferred Pharmaceuticals, Inc recalls Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09)
Hazard: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
March 27, 2019DrugsFDA
Legacy Pharmaceutical Packaging LLC recalls Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, M
Hazard: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
March 27, 2019DrugsFDA
Legacy Pharmaceutical Packaging LLC recalls Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Man
Hazard: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
March 27, 2019DrugsFDA
Legacy Pharmaceutical Packaging LLC recalls Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Man
Hazard: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
March 27, 2019DrugsFDA
American Health Packaging recalls Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: Amer
Hazard: CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
March 27, 2019DrugsFDA
AVKARE Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufa
Hazard: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
March 27, 2019DrugsFDA
AVKARE Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufac
Hazard: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
March 27, 2019DrugsFDA
AVKARE Inc. recalls Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski,
Hazard: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
March 27, 2019DrugsFDA
Camber Pharmaceuticals Inc recalls Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000
Hazard: CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
March 27, 2019DrugsFDA
Camber Pharmaceuticals Inc recalls Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000
Hazard: CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
March 27, 2019DrugsFDA
Camber Pharmaceuticals Inc recalls Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1
Hazard: CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
March 27, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macl
Hazard: CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
March 27, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
March 27, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 6
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
March 27, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
March 27, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton,
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
March 27, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Ste
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42
Hazard: Lack of Assurance of Sterility