Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2013-06-12FDA-DrugPentec HealthClass IIIDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
- 2013-06-12FDA-DrugPentec HealthClass IIFresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
- 2013-06-12FDA-DrugPentec HealthClass IIBaxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
- 2013-06-12FDA-DrugPentec HealthClass IIBaxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
- 2013-06-12FDA-DrugPentec HealthClass IIProplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
- 2013-06-12FDA-DrugLegacy Pharmaceutical Packaging LLCClass IIILorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
- 2013-06-12FDA-DrugPetnet Solution IncClass IIFludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN
cGMP Deviation
- 2013-06-12FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIIDisulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01
CGMP Deviation; cotton coil is missing in some packaged bottles
- 2013-06-12FDA-DrugNovartis Consumer HealthClass IIIVoltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405), Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ.
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
- 2013-06-12FDA-DrugNovartis Consumer HealthClass IIILamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
- 2013-06-12FDA-DrugNovartis Consumer HealthClass IIINovartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health, Inc., Parsippany, NJ. UPC code: 300673999428.
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
- 2013-06-12FDA-DrugNovartis Consumer HealthClass IIITarget Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis, MN.
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot..
- 2013-06-12FDA-DrugNovartis Consumer HealthClass IIINovartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC code: 0067-3998-12; (c) 30 gm (1 oz), packaged with UPC code: 300673998308 and NDC code: 0067-3998-30; (d) 30 gm (1 oz), packaged with UPC code: 300673998339 and NDC code: 0067-3998-33.
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IITri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIMIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIPraziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IICarnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIMorphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IITestosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIMIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIPhosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIB-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIAscorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIProcaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIMethylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIMitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IILipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIGlutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IISodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIHydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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