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THE COMPOUNDING SHOP Recalls
25 recalls on record · June 12, 2013 to June 12, 2013 · Drugs
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Sho
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compoundi
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Peter
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
June 12, 2013DrugsFDA
THE COMPOUNDING SHOP, INC. recalls Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.