FDA recalls: August 2014
Every food and drug recall report the FDA published in August 2014: 190 reports, 31 of them Class I.
- Recall reports
- 190
- Class I (serious)
- 31
- Food
- 118
- Drugs
- 72
- Aug 27, 2014Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx onlyDrug · Mylan Pharmaceuticals Inc.Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.Class III
- Aug 27, 2014DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, M…Drug · Hospira Inc.Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.Class I
- Aug 27, 2014Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottl…Drug · Wockhardt Usa Inc.Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.Class II
- Aug 27, 2014ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx on…Drug · Baxter Healthcare CorpPresence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).Class II
- Aug 27, 2014CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distr…Drug · Ben Venue Laboratories IncLack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.Class II
- Aug 27, 2014Triveen - PRx RNF Capsules, 30-count bottles, Rx onlyDrug · Trigen Laboratories, Inc.Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.Class III
- Aug 27, 2014PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP P…Drug · Fresenius Kabi USA, LLCCGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.Class II
- Aug 27, 2014Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Cre…Drug · Pharmacy CreationsNon-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.Class I
- Aug 27, 2014Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For IDrug · Hospira Inc.Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic…Class I
- Aug 27, 2014ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV,…Drug · US Compounding IncLabeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the a…Class II
- Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle
- 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Heal…
- fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Instit…
- fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0
- fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0
- fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Instit…
- fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0
- Jody's, Funfetti
- Jody's, Freedom Funfetti
- Jody's, Breast Cancer Awareness Kettle Corn
- Organic Carob Powder
- Product is in a 160 gram, light green tin container, labeled in part: "ecoato Sweet Pap…
- Ciranda Organic Carob Powder Light, Product Code 20030
- Natural Grocers Organic Chunks of Energy Carob Supergreens, 0
- Natural Grocers Organic Chunks of Energy Date Flax Turmeric, 0
- CaCoCo Superfood Drinking Chocolate
- CaCoCo Superfood Drinking Chocolate
- XOCHITL(so cheel) Chipotle Queso Dip
- XOCHITL(so cheel) Chipotle Queso Dip
- Chile Con Queso
- American Spoon Food Sour Cherry Marmalade, 9
- Sesame Ginger Dressing sold under the Whole Foods Market brand in plastic jars, 14 oz
- FISH FAMILY FARM INC
- FISH FAMILY FARM INC
- FISH FAMILY FARM INC
- FISH FAMILY FARM INC
- FISH FAMILY FARM INC
- Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metaboli…
- Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement
- E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured b…
- Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Sin…
- Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactur…
- Allegro Original Marinade, 12
- Ronzoni Roasted Garlic Fettuccine Net Wt
- Ocean Garden Wild Co-treated Steak IVP 10LB 10 oz
- Frederick Farms 4oz chocolate ice cream cups
- Uncle Ben's(R) Ready Rice GARDEN VEGETABLE, with PEAS, CARROTS, AND CORN
- Shelled walnuts, 8 oz
- Mrs. Fields Milk Chocolate Chip Cookies, Net Wt. 8 oz (227 g) cardboard carton with 8 i…
- Lindberg B-Complex, 50mg, 60 capsules (UPC 092865236601), 120 capsules (UPC 0928652…
- Fitness Labs Fitness Multi 1, 90 capsules (UPC 654186946555) and 180 capsules (UPC 6541…
- Fitness Labs Fitness Multi 2, 90 capsules (UPC 654186946203) and 180 capsules (UPC 6541…
- Lindberg B-Complex, 100mg, 60 capsules (UPC 092865239602), 240 capsules (UPC 0928652…
- Part Skim Ricotta cheese: SYSCO Imperial Ricotta Cheese packaged in 5 pound tubs and Sa…
- Sargento Fat Free Ricotta Natural Cheese and Dutch Farms Fat Free Ricotta Cheese packag…
- Sargento Light Ricotta Natural Cheese packaged in 15 ounce plastic tubs
- Sargento Whole Milk Ricotta Natural Cheese packaged in 15 ounce plastic tubs
- Farimont Foods Ricotta Cheese packaged in 30 pound bags
- Cool Tropics Rips Slush, Sour Apple Flavored 100% Juice No artificial colors or flavors…
- Cool Tropics Rips Slush, Blue Raspberry Flavored 100% Juice No artificial colors or fla…
- Cool Tropics Rips Slush, Cherry LimeadeFlavored 100% Juice No artificial colors or flav…
- Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) a…
- Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) a…
- Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufact…
- buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Ma…
- Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pha…
- Alprazolam Tablets, USP 0
- Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufacture…
- Tetrahydrozoline HCL, 16 kg drum
- Alcohol-Free Hand Sanitizer, 1
- Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and…
- Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial
- BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ…
- Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml via…
- Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use…
- Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial,…
- MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple…
- Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml,…
- Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials…
- B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep S…
- Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or…
- Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufactured by: CB Inc
- G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Mult…
- L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep S…
- Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep…
- Simply Enjoy Chocolate Chip Walnut Cookies, 7oz
- KIND HEALTHY GRAINS Maple Pumpkin Seed Bar, 35g, packaged in a purple, black and transp…
- STRONG & KIND Honey Smoked BBQ Almond Protein Bar, 45g, packaged in a red, black and tr…
- STRONG & KIND Roasted Jalapeno Almond Protein Bar, 45g, packaged in a green, black and…
- STRONG & KIND Honey Mustard Almond Protein Bar, 45g, packaged in a yellow, black and tr…
- STRONG & KIND Hickory Smoked Almond Protein Bar, 45g, packaged in a grey, black and tra…
- STRONG & KIND Thai Sweet Chili Almond Protein Bar, 45g, packaged in a purple, black and…
- Traditional Hummus sold under the Archer Farms brand and packaged in either a transpare…
- Roasted Garlic Hummus sold under the Archer Farms brand and packaged in a transparent p…
- Roasted Red Pepper Hummus sold under the Archer Farms brand and packaged in a transpare…
- Chipotle Hummus sold under the Giant Eagle Market District brand and packaged in a tran…
- Garlic Hummus sold under the Giant Eagle Market District brand and packaged in a transp…
- Edamame Hummus sold under the Trader Joe's brand and packaged in a transparent plastic…
- 5 Layer Fiesta Dip sold under the Trader Joe's brand and packaged in a transparent plas…
- Spicy Yellow Lentil Hummus sold under the Eat Well Embrace Life brand and packaged in a…
- MuscleTech Amino Build, Fruit Punch flavored, Net Wt
- Beirut Lift Turnips Pickles
- Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist
- Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only…
- OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only
- Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU…
- Dermamedics Calm & Correct Cream in 2 oz
- Dermamedics Baby's Relief Calm and Repair Cream in 2 oz
- Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50…
- Dermamedics Calm and Correct Serum, 2 oz
- Dermamedics Post Procedure Cream 1 oz
- Dermamedics Calm and Correct Cream 2 oz
- Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml container…
- Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml container…
- Fagron, Phytobase Cream, 500 g, Article number: 802156
- Fagron, Pentravan Base 2
- Fagron, Pentravan Plus Base 2
- triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AM…
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bo…
- Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx O…
- Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for…
- Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12
- Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25…
- Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for:…
- Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for…
- Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12
- Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 c…
- Alprazolam Tablets, USP, 0
- SEQUATCHIE COVE CREAMERY, CUMBERLAND (cheese), 320 DIXON COVE ROAD, SEQUATCHIE, TN 37374
- Malt-O-Meal Frosted Flakes, item number 00955
- Market Pantry Apple
- Market Pantry Apple Cinnamon
- fruty U applesauce, apple
- fruty U applesauce, apple cinnamon
- HyVee applesauce
- Richards Too Good BBQ Sauce
- Richards Too Good Hot Sauce
- Richards Too Good Teriyaki Sauce
- Professional Bak-klene All Purpose No-Stick Bakery Spray, packaged in 14-oz
- Original Silk Light Soymilk Half Gallon, Distributed by WhiteWave Foods Broomfield, Col…
- Whole Foods Caesar Salad Mini Net Wt 4 0z plastic shell
- Whole Foods Mesclun Goat Cheese Salad Mini Net Wt 4 0z plastic shell
- King of Pops Key Lime Pie, frozen flavored pop cycle
- King of Pops Banana Puddin', frozen flavored pop cycle
- Tiger-X, Blister Packs
- Samurai-X, Blister Packs
- Samurai Gold, Blister Packs
- Gold, Blister Packs
- Oyavon, Blister Packs
- Adam, Blister Packs
- Actimeta, Blister Packs
- Affirm XL, Blister Packs
- Platinum A, Blister Packs
- Platinum B, Blister Packs
- Ninja Mojo, small vinyl Packs
- Single Mojo, small vinyl Packs
- Double Mojo, small vinyl Packs
- Ginseng Power, Blister Packs
- Calcium Formula, 250 cc HDPE Bottles
- Green Coffee Bean
- Shark Formula, 250 cc HDPE Bottles
- Bitter Melon, 225cc HDPE Bottle
- Chanca Piedra, 225cc HDPE Bottles
- Rinozan, 250cc HDPE Bottles
- Una De Gato, 225cc HDPE Bottle
- Saw Palmetto, Glass Bottle
- Garcinia Cambogia, 225cc HDPE Bottle
- BTI Lean Formula, 400cc HDPE Bottle
- DMSA, 100cc HDPE bottle
- Noni Supplement, Capsules
- Therapeutic Care A, B, C, 225cc HDPE Bottles for A,B
- Actra-SX, Vinyl Bags
- Maxium, Capsules
- Serrapeptase, 100cc HDPE Bottles
- Garcinia Series, Capsules
- Mega Jex, Capsules
- Chitosan, Blister Pack
- Garcinia Cambogia Extract, Capsules
- Nano Papa
- Kidney&Chi Plus, Bottles
- Detoxification Plus, Bottles
- Longetivity Plus, Bottles
- Stomach & Spleen Plus, Bottles
- Bone & Joint Plus, Bottles
- Circulation and Energy Formula, Bottles
- Tendon & Muscle Plus, Bottles
- Vital Balance Formula, Bottles
- Via-Max Gold, Blister packs
- Albert, Capsules
- CKLS, Capsules
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