April 17, 2019DrugsFDA
Lohxa LLC recalls Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
April 17, 2019DrugsFDA
AVKARE Inc. recalls Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --
Hazard: Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
April 17, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.,
Hazard: Failed Impurities/Degradation Specifications; 18 month long term stability study.
April 17, 2019DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No
Hazard: Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
April 17, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b) 90-count (NDC: 13
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
April 17, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b) 90-count (NDC:
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
April 17, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 1
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
April 17, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
April 17, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-count
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
April 17, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle,
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
April 17, 2019DrugsFDA
LUPIN SOMERSET recalls Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufacture
Hazard: Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
April 17, 2019DrugsFDA
McDaniel Life-Line LLC recalls Life-Line tm Catalytic Activated Energy Water, 1 gallon container, McDaniel Life-Line LLC 1775 US Hwy 385 806-647-1741 D
Hazard: Unapproved new drug
April 17, 2019DrugsFDA
McDaniel Life-Line LLC recalls Indian Herb Paste (a dietary supplement) Ingredients: Galangal, Indian Paint, Yellow Dock & Licorice in an alloy of Life
Hazard: Unapproved new drug
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 15-0.25MG-6MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd.
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blv
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd.
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blv
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Professional Compounding Pharmacy, 996 NW Circle
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 16.6-0.55 MG-11.1 MCG/ML* INJECTABLE, 10 ml, Professional Compounding Pharmacy, 996 NW Circ
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corval
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE 15-0.5MGMG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corva
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10ml, Professional Compounding Pharmacy, 996
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.5ml, Professional Compounding Pharmacy, 996
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, Professional Compounding Pharmacy, 996 NW Ci
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.