The Recall Desk

Archive

May 2013 recalls

607 recalls were announced in May 2013.

What the numbers show

Critical
23
Severe
225
High
139
Moderate
183
Low
37

Of the 607 recalls this month scored against our rubric, 4% are Critical, 37% are Severe.

Which agencies issued them

201–300 of 607

  • SevereFDA (Drugs)·D-339-2013·2013-05-22

    FDA Recalls Acetylcysteine Injection Due to Sterility Assurance Concerns

    Green Valley Drugs is recalling Acetylcysteine Injection vials because the pharmacy could not ensure the products were sterile.

    Product
    Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-397-2013·2013-05-22

    Green Valley Drugs Recalls Nandrolone Decanoate Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Nandrolone Decanoate Injection because the pharmacy could not ensure the sterility of the compounded products.

    Product
    Nandrolone Decanoate Injection, all strengths and all presentations including a) Nandrolone Decanoate 300 mg/mL, b) Nandrolone 200 mg/mL, c) Nandrolone 250 mg/mL, d) Nandrolone 350 mg/mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-326-2013·2013-05-22

    Unapproved Male Enhancement Supplements Containing Tadalafil Recalled Nationwide

    InSo-Independent Contractor for West Coast Nutritionals, LTD is recalling three unapproved male enhancement products found to contain undeclared tadalafil.

    Product
    a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.FIRMINITE.COM, b) Libidron 410 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.LIBIDRON.COM , c)Extra Strength Instant Hot Rod 496 mg is…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-361-2013·2013-05-22

    Green Valley Drugs Recalls Edetate Disodium Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Edetate Disodium Injection because the pharmacy could not ensure the sterility of the compounded products.

    Product
    Edetate Disodium Injection, all strengths and all presentations including a) Edetate Disodium 150/30 mL and b) Edetate Disodium 150/100 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-395-2013·2013-05-22

    Green Valley Drugs Recalls MIC Vitamin Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 588 vials and syringes of MIC Vitamin Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    MIC Vitamin Injection, all strengths and all presentations including a) MIC 25-50-25-30 mL, b) MIC_B_COMP-B12-25-50-50-1000-30 mL, c) MIC_B12-25-50-25-400-30 mL, d) MIC_B6_B12-30 mL, e) MIC_METH_VIT-#3-30 m, f) MIC_METH-25-50-50-1000 mcg 30 mL, g) MIC_ULTRA-30 mL, h)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-333-2013·2013-05-22

    FDA Recalls Unapproved Libigrow XXXTREME Capsules Containing Undeclared Ingredients

    The FDA is recalling Libigrow XXXTREME Capsules because they were marketed without approval and may contain undeclared sildenafil, tadalafil, and analogues.

    Product
    libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By Kretek International, Inc. Moorpark, CA 930210 1 count blister: UPC 705105830735, 5 count blister: UPC 610585435939, 10 count blister: UPC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-385-2013·2013-05-22

    Green Valley Drugs Recalls Manganese Sulfate Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Manganese Sulfate Injection because the pharmacy could not ensure the sterility of the compounded products.

    Product
    Manganese Sulfate Injection, all strengths and all presentations including a) Manganese-0.1 30 mL, b) Manganese Sulfate 0.1 mg/30 mL, c) Manganese Sulfate 5 mg/5 mg, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-403-2013·2013-05-22

    Green Valley Drugs Recalls Pyridoxine Hydrochloride Injection for Sterility Concerns

    Green Valley Drugs is recalling Pyridoxine Hydrochloride Injection due to lack of assurance of sterility and quality control concerns.

    Product
    Pyridoxine Hydrochloride Injection, all strengths and all presentations including Pyridoxine 100 mg/mL 30 mL, 50 mL, and 10 mL PF SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-414-2013·2013-05-22

    Green Valley Drugs Recalls Thiamine Hydrochloride Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Thiamine Hydrochloride Injection because the compounding pharmacy could not ensure the sterility of the products.

    Product
    Thiamine Hydrochloride Injection, all strengths and all presentations including a) Thiamine 100 mg/30 mL, b) Thiamine Hydrochloride 100 mg/mL with preservative 30 mL, c) Thiamine Hydrochloride 50 mg/mL with preservative 30 mL, d) Thiamine Hydrochloride 100 mg/mL preservative…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-354-2013·2013-05-22

    Green Valley Drugs Recalls Vitamin D3 Injections Due to Sterility Concerns

    Green Valley Drugs is recalling Vitamin D3 injections because the pharmacy could not ensure the products were sterile. The recall covers 18 vials distributed nationwide.

    Product
    Vitamin D3 Injection, all strengths and all presentations including a) Cholecalciferol D3 50,000iu 30 mL, b) Calcitriol D3 10,000iu, and c) Calcitriol D3 50,000iu, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-357-2013·2013-05-22

    Green Valley Drugs Recalls Dexamethasone Sodium Phosphate Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Dexamethasone Sodium Phosphate Injection because the compounding pharmacy could not ensure the sterility of the products.

    Product
    Dexamethasone Sodium Phosphate Injection, all strengths and all presentations including a) Dexamethasone Sodium Phosphate 10 mg/1 mL, b) Dexamethasone Sodium Phosphate 10 mg/mL PF 1 mL, c) Dexamethasone Sodium Phosphate 4 mg/30 mL, d) Dexamethasone-4 mg/5 mL P.F., Rx only, Green…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-402-2013·2013-05-22

    FDA Recalls Green Valley Drugs Progesterone Injection for Sterility Concerns

    Green Valley Drugs is recalling all Progesterone Injection products due to a lack of assurance of sterility and quality control concerns.

    Product
    Progesterone Injection, all strengths and all presentations including a) Progesterone 100 mg/mL 10 mL, 30 mL b) Progesterone 50 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-353-2013·2013-05-22

    Green Valley Drugs Recalls Buprenorphine Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling Buprenorphine Injection due to lack of assurance of sterility and quality control concerns.

    Product
    Buprenorphine Injection, all strengths and all presentations including Buprenorphine-0.3 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-370-2013·2013-05-22

    Green Valley Drugs Recalls Human Chorionic Gonadotropin Injections for Sterility Concerns

    Green Valley Drugs is recalling Human Chorionic Gonadotropin (HCG) injections due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-367-2013·2013-05-22

    Green Valley Drugs Recalls Furosemide Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Furosemide Injection vials because the pharmacy could not ensure the products were sterile. The recall covers 227 vials distributed nationwide.

    Product
    Furosemide Injection, all strengths and all presentations including a) Furosemide PF-10 mg-10 mL, b) Furosemide PF-10 mg-2 mL SDV, and Furosemide 10 mg/mL 4 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-401-2013·2013-05-22

    Green Valley Drugs Recalls Procaine Hydrochloride Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling 70 vials of Procaine Hydrochloride Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Procaine Hydrochloride Injection, all strengths and all presentations, including a) Procaine 2% 30 mL PF, b) Procaine HCl 2% 10 mL, c) Procaine HCl 20 mg/mL 30 mL, d) Procaine HCl 1% 50 mL MDV, e) Procaine HCl 1% PF 5 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1385-2013·2013-05-22

    Heartland Gourmet Gluten Free Cookie Mix Recalled for Undeclared Milk

    Heartland Gourmet is recalling specific lots of gluten-free chocolate chip cookie mix labeled as dairy-free because they contain milk.

    Product
    Heartland Gourmet Gluten Free chocolate chip cookie mix, DAIRY FREE, packaged in 16-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1391-2013·2013-05-22

    Eastland Food Recalls Asia Best Salted Mackerel Due to Histamine Levels

    Eastland Food Corporation is recalling 210 cases of Asia Best Salted Mackerel because histamine levels indicate product decomposition.

    Product
    Asia Best Salted Mackerel, 7 oz. vacuum packages, 25 pkgs/cases; labeled in part ***Eastland Food Corp. 8305 Stayton Drive Jessup, MD 20794 *** Product of Thailand *** Keep Frozen *** UPC 851035 408024***
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-408-2013·2013-05-22

    Green Valley Drugs Recalls Sodium Chloride Injection Due to Sterility Concerns

    Green Valley Drugs is recalling 318 vials of Sodium Chloride Injection due to a lack of assurance of sterility and quality control concerns.

    Product
    Sodium Chloride Injection, all strengths and all presentations including a) Bacteriostatic Sodium Chloride 0.9% 30 mL, b) Sodium Chloride 23.4% 30 mL PF, and c) Sodium Chloride 23.4% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-324-2013·2013-05-22

    Gilead Recalls Vistide Injection Due to Particulate Matter

    Gilead Sciences is recalling Vistide (cidofovir) injection vials because particulate matter was found in some units. The recall covers 3,181 vials distributed in the US, Canada, and UK.

    Product
    Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, UPC 3 61958 01011 5; NDC 61958-0101-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-381-2013·2013-05-22

    Green Valley Drugs Recalls Lipotropic Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 176 vials of Lipotropic With Vitamins with Methylcobalamin Injections nationwide due to a lack of assurance of sterility.

    Product
    Lipotropic With Vitamins with Methylcobalamin Injections, all strengths and all presentations including a) Lipo w/Vitamins-methylcobalamin 100 mL, 30 mL, and b) Lipo w/ Vitamins, Folic, Methylcobalamin 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-374-2013·2013-05-22

    Green Valley Drugs Recalls Hydroxocobalamin Injection Due to Sterility Concerns

    Green Valley Drugs is recalling 135 vials of Hydroxocobalamin Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Hydroxocobalamin Injection, all strengths and all presentations including a) Hydroxocobalamin 1000 mcg/mL 30mL and b) Hydroxocobalamin 1000 mcg/mL 10 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-375-2013·2013-05-22

    Green Valley Drugs Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling 229 vials of Hydroxyprogesterone Caproate Injection nationwide due to lack of assurance of sterility.

    Product
    Hydroxyprogesterone Caproate Injection, all strengths and all presentations including Hydroxyprogesterone Caproate 250 mg/mL 1 mL, 4 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-365-2013·2013-05-22

    Green Valley Drugs Recalls Estradiol Valerate Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Estradiol Valerate Injection vials because the pharmacy could not ensure the products were sterile. This affects 243 vials distributed nationwide.

    Product
    Estradiol Valerate Injection, all strengths and all presentations including a) Estradiol Valerate 40-10 mL and b) Estradiol Valerate 40-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1342-2013·2013-05-22

    Centerville Pie Company Recalls Clam Pies Due to Undeclared Anchovies

    Centerville Pie Company is recalling 52 clam pies sold in Massachusetts because they contain undeclared anchovies, a potential allergen risk.

    Product
    Centerville Pie Company Clam Pie, 2 lb (Large) and 1 lb (Small)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1408-2013·2013-05-22

    Lisy Corp. Recalls Sazonador de Carnes Meat Seasoning for Undeclared Soy

    Lisy Corp. is recalling Sazonador de Carnes meat seasoning in 5 oz, 14 oz, and 28 oz sizes due to undeclared soy. The product was distributed in 12 states.

    Product
    Sazonador de Carnes (Meat Seasoning) in 5 oz, 14 oz, and 28 oz
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-340-2013·2013-05-22

    Green Valley Drugs Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Alpha Lipoic Acid Injection vials because the pharmacy could not ensure the products were sterile.

    Product
    Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-341-2013·2013-05-22

    Green Valley Drugs Recalls Amikacin Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Amikacin Injection because the pharmacy could not ensure the sterility of the compounded products. The recall covers all strengths and presentations of the drug.

    Product
    Amikacin Injection, all strengths and all presentations including 50, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-390-2013·2013-05-22

    Green Valley Drugs Recalls Methylprednisolone and Bupivacaine Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling Methylprednisolone and Bupivacaine Injection due to a lack of assurance of sterility and quality control concerns.

    Product
    Methylprednisolone and Bupivacaine Injection, all strengths and all presentations including Methylpred80mg/bupivacaine0.25% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-376-2013·2013-05-22

    Green Valley Drugs Recalls Ketorolac Injection Due to Sterility Concerns

    Green Valley Drugs is recalling 3,289 vials of Ketorolac Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Ketorolac Injection, all strengths and all presentations including a) Ketorolac 30 mg/mL 10 mL MDV, b) Ketorolac 30 mg/mL 2 mL SDV, c) Ketorolac 30 mg/mL 1 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-406-2013·2013-05-22

    Green Valley Drugs Recalls Nandrolone and Testosterone Injections for Sterility Concerns

    Green Valley Drugs is recalling Nandrolone Decanoate and Testosterone Cypionate injections due to a lack of assurance of sterility and quality control concerns.

    Product
    Nandrolone Decanoate and Testosterone Cypionate Injection, all strengths and all presentations including a) Nandrolone 100 mg/mL TestCyp 100 mg/mL 10 mL and b) Nandrolone 100 mg/mL TestCyp 200 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1409-2013·2013-05-22

    Lisy Corp. Recalls Sazon Perfecta Seasoning Due to Undeclared Soy

    Lisy Corp. is recalling Sazon Perfecta seasoning in 4 oz, 12 oz, and 24 oz packages because it contains undeclared soy.

    Product
    Sazon Perfecta (Perfect Seasoning) in 4 oz, 12 oz, and 24 oz
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-412-2013·2013-05-22

    Green Valley Drugs Recalls Sterile Testosterone and Nandrolone Injections

    Green Valley Drugs is recalling specific lots of sterile hormone injections due to a lack of assurance of sterility and quality control concerns.

    Product
    Testosterone Propionate, Testosterone Cypionate, and Nandrolone Decanoate Injection, all strengths and all presentations including Test Prop 100 mg/Test Cyp 50 mg/nandro dec 150 mg/ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-323-2013·2013-05-22

    Super Power capsules recalled for containing unapproved sildenafil

    D& S Herbals, LLC is recalling Super Power capsules because they contain sildenafil, an unapproved drug ingredient.

    Product
    Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading, NJ 08863, UPC 7 18122 90678 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-399-2013·2013-05-22

    Green Valley Drugs Recalls Phosphatidylcholine Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Phosphatidylcholine and Sodium Deoxycholate Injection due to a lack of assurance of sterility in compounded products.

    Product
    Phosphatidylcholine and Sodium Deoxycholate Injection, all strengths and all presentations including Phospha_Deoxy-35-30-50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1383-2013·2013-05-22

    Carson's Assorted Cookie Pack Recalled for Undeclared Allergens

    Carson's Country Market is recalling Assorted Cookie Packs sold in New York due to undeclared walnuts, wheat, milk, and peanut butter.

    Product
    CARSON'S HOMEMADE PIES AND OTHER GOOD THINGS brand ASSORTED COOKIE PACK Chocolate Chip - Fudge Brownie - Vanilla Drop - Molasses - Oatmeal Raisin - Peanut Butter - Pumpkin, NET WT. 14 OZ., UPC 7 53182 15240 0 --- Sanborn, NY 14132 --- The cookies are packaged in clear, hard…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-388-2013·2013-05-22

    Green Valley Drugs Recalls Methylprednisolone and Marcaine Injections for Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling 607 vials of Methylprednisolone Acetate and Marcaine Injection due to lack of assurance of sterility and quality control concerns.

    Product
    Methylprednisolone Acetate and Marcaine Injection, all strengths and all presentations including a) Methylpred 80 mg/mL and Marcaine 0.25%-2.75, b) Methylpred_Marc-0.25-0.27, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-411-2013·2013-05-22

    Green Valley Drugs Recalls Taurine Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Taurine Injection products because the compounding pharmacy lacked assurance of sterility and had quality control concerns.

    Product
    Taurine Injection, all strengths and all presentations including a) Taurine 50 mg/mL, b) Taurine-50-30 mL, c) Taurine-50 mg-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1386-2013·2013-05-22

    Heartland Gourmet Gluten Free Pizza Crust Mix Recalled for Milk Mislabeling

    Heartland Gourmet is recalling gluten-free pizza crust mix labeled as dairy-free but containing milk. The recall affects 204 boxes distributed to schools, online, and retail in TX, MN, CO, and Canada.

    Product
    Heartland Gourmet Gluten Free rosemary basil pizza crust mix, DAIRY FREE, packaged in 15.4-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-398-2013·2013-05-22

    Green Valley Drugs Recalls Phenylephrine Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Phenylephrine Injection vials because the pharmacy could not ensure the products were sterile.

    Product
    Phenylephrine Injection, all strengths and all presentations including Phenylephrine 1% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2013·2013-05-22

    Integra Recalls BioMend Extend Membranes Due to Pyrogen Levels

    Integra LifeSciences is recalling BioMend Extend Absorbable Collagen Membranes because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1291-2013·2013-05-22

    Integra Recalls Collagen Wound Dressings Due to Pyrogen Levels

    Integra LifeSciences is recalling 49,500 boxes of Colla Tape Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1317-2013·2013-05-22

    ConMed Recalls PadPro Adult Radiotransparent Multifunction Electrodes Due to Connector Damage

    ConMed is recalling PadPro Adult Radiotransparent Multifunction Electrodes because damaged connector tooling may pinch lead wire filaments, potentially preventing the device from delivering appropriate energy or causing injury.

    Product
    PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2013·2013-05-22

    Integra Absorbable Collagen Sponge Recalled for Pyrogen Levels

    Integra LifeSciences is recalling absorbable collagen sponges due to a process deviation that may have resulted in higher pyrogen levels than permitted.

    Product
    Absorbable Collagen Sponge Provided As Intermediate to Another Company
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1288-2013·2013-05-22

    Integra Recalls INSTAT Hemostatic Agent Due to Pyrogen Levels

    Integra LifeSciences is recalling INSTAT absorbable hemostatic agent because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1399-2013·2013-05-22

    Grippo's Bar-B-Q Potato Chips Recalled Due to Metal Fragments

    Grippo Potato Chip Co. is recalling Bar-B-Q flavored potato chips after an inspection found metal fragments in the salt hopper.

    Product
    Grippo's BAR-B-Q FLAVORED POTATO CHIPS, 1oz, 1 1/8oz, 1¿oz, 3.5oz, 8oz, 12oz bags & 1.5lb boxes, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, SUGAR, TORULA YEAST, SPICES, MONOSODIUM GLUTAMATE, CORN FLOUR ONION POWDER, GARLIC POWDER, NATURAL HICKORY SMOKE FLAVOR…
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1286-2013·2013-05-22

    Integra NeuraWrap Nerve Protector Recalled for Pyrogen Levels

    Integra LifeSciences is recalling 954 boxes of NeuraWrap Nerve Protector because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1389-2013·2013-05-22

    Hong Chang Recalls Frozen Oyster Meat Due to Insanitary Conditions

    Hong Chang Corporation is recalling frozen Hokkai oyster meat because it was prepared under insanitary conditions, potentially rendering it injurious to health.

    Product
    Hokkai Medium/Large Size Oyster Meat I.Q.F., 4 lbs x 6.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1405-2013·2013-05-22

    Gruma Senora Verde Taco Dinner Kit Recalled for Undeclared Wheat

    Gruma Corp is recalling Senora Verde Taco Dinner Kits because they contain undeclared wheat, posing a risk to individuals with wheat allergies or celiac disease.

    Product
    Senora Verde Taco Dinner Kit, 12ct, 9.75 oz (276g), 12 cartons per case.
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·13V217000·2013-05-22

    Fleetwood Recalls 2014 Motorhomes Due to Loose Solar Panel Fasteners

    Fleetwood RV is recalling 2014 motorhomes because solar panel fasteners may loosen, causing the panel to separate and create a road hazard.

    Product
    FLEETWOOD — FLEETWOOD, AMERICAN COACH DISCOVERY, EXPEDITION, AMERICAN REVOLUTION, BOUNDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1311-2013·2013-05-22

    Karl Storz Recalls Sterile Electrode Accessories Due to Packaging Damage

    Karl Storz is recalling 9,432 units of sterile electrode accessories because damaged packaging may allow airborne contamination.

    Product
    Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1290-2013·2013-05-22

    Integra Recalls Helitene Absorbable Collagen Hemostatic Sponge

    Integra LifeSciences is recalling Helitene Absorbable Collagen Hemostatic Sponge because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F1402-2013·2013-05-22

    Grippo's Potato Chips Recalled Due to Metal Fragments in Salt Hopper

    Grippo Potato Chip Co. is recalling Hot Dill Pickle Potato Chips after an inspection found metal fragments in the salt hopper.

    Product
    Grippo's HOT DILL PICKLE Artificially Flavored Potato Chips, 1¿oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, WHEY, MALTODEXTRIN, MODIFIED CORN STARCH, SUGAR, MONOSODIUM GLUTAMATE, SODIUM DIACETATE, SPICES, ONION, GARLIC VINEGAR SOLIDS, NATURAL AND…
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1398-2013·2013-05-22

    Grippo's Potato Chips Recalled Due to Metal Fragments in Salt Hopper

    Grippo Potato Chip Co. is recalling various sizes of potato chips after an inspection found metal fragments in the salt hopper.

    Product
    Grippo's Potato Chips, 1oz, 1 1/8oz , 1¿oz, 3.5oz, 8oz, 12oz bags & 1.5lb boxes, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT. www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 61701 5 Product Quantity Distributed…
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1301-2013·2013-05-22

    Integra Recalls BioMend Membranes Due to Pyrogen Levels

    Integra LifeSciences is recalling BioMend Absorbable Collagen Membranes because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1404-2013·2013-05-22

    Nuts Are Good! Recalls Island Mix for Undeclared Allergens

    Nuts Are Good! Inc. is recalling Island Mix because it contains undeclared peanuts, cashews, and almonds, posing a risk to allergic consumers.

    Product
    Island Mix, 12 oz. with best by date of 02/17/2014
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-407-2013·2013-05-22

    Green Valley Drugs Recalls Sodium Bicarbonate Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling 6,213 vials of Sodium Bicarbonate Injection due to a lack of assurance of sterility.

    Product
    Sodium Bicarbonate Injection, all strengths and all presentations including: a) Sodium Bicarb 4.2% 5 mL PF, b) Sodium Bicarb 8.4% 50 mL SDV, c) Sodium Bicarbonate 8.4%, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2013·2013-05-22

    Integra Layershield Adhesion Barrier Matrix Recalled for Pyrogen Levels

    Integra LifeSciences is recalling 215 boxes of Layershield Adhesion Barrier Matrix because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1298-2013·2013-05-22

    Integra Recalls OraMem Absorbable Collagen Membrane Due to Pyrogen Levels

    Integra LifeSciences is recalling 812 boxes of OraMem Absorbable Collagen Membrane because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1393-2013·2013-05-22

    Dried Mango Recalled for Undeclared Sulfites and Preservatives

    S & M International Inc. is recalling Dried Mango (3.5oz.) due to undeclared sulfites and preservatives found during sampling.

    Product
    Dried Mango (3.5oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Product of China. Item No. 802578.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1324-2013·2013-05-22

    Varian Segmented Cylinder Applicator Set Recalled for Potential Slippage During Treatment

    Varian Medical Systems is recalling 21 Segmented Cylinder Applicator Sets used for brachytherapy because they may slip during treatment, causing radiation to be delivered to areas outside the target.

    Product
    Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1400-2013·2013-05-22

    Grippo's Sweet Bermuda Onion Flavored Potato Chips Recalled for Metal Fragments

    Grippo Potato Chip Co. is recalling Sweet Bermuda Onion Flavored Potato Chips due to metal fragments found in the salt hopper during an inspection.

    Product
    Grippo's Sweet BERMUDA ONION FLAVORED POTATO CHIPS, 1oz, 1¿oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, SWEET BERMUDA ONION SEASONING***www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 61703 9
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1322-2013·2013-05-22

    Edwards Lifesciences Recalls Proplege Coronary Sinus Catheters Due to Leakage

    Edwards Lifesciences is recalling Proplege Coronary Sinus Catheters, model PR9, because of confirmed blood leakage through the hemostasis valve in the kitted introducer.

    Product
    Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1285-2013·2013-05-22

    Integra Recalls DuraGen XS Dural Regeneration Matrix Due to Pyrogen Levels

    Integra LifeSciences is recalling 52 boxes of DuraGen XS Dural Regeneration Matrix because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2013·2013-05-22

    Integra OraTape Collagen Wound Dressing Recalled for Pyrogen Levels

    Integra LifeSciences is recalling OraTape Absorbable Collagen Wound Dressings because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1381-2013·2013-05-22

    Early Bird Foods Recalls Granola Snack Mix for Undeclared Soya Lecithin

    Early Bird Foods & Co. is recalling CHOC-A-DOODLE-DOO granola snack mix due to undeclared soya lecithin. The product was distributed in six states.

    Product
    Early Bird Foods & Co. CHOC-A-DOODLE-DOO featuring DARK CHOCOLATE & COCONUT granola snack mix, Net Wt. 12 oz packaged in clear plastic bag. Each case contains 12 packages. UPC: 6 89466 30000 0.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1327-2013·2013-05-22

    Hologic Fluoroscan Mini C-arm InSight2 Recalled for Inaccurate Irradiation Time Alarms

    Hologic is recalling Fluoroscan Mini C-arm InSight2 systems because the audible alarm and total cumulative irradiation time displays are inaccurate.

    Product
    Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1297-2013·2013-05-22

    Integra Ora Plug Collagen Wound Dressing Recalled for Pyrogen Levels

    Integra LifeSciences is recalling Ora Plug Absorbable Collagen Wound Dressings due to potential pyrogen levels exceeding specifications.

    Product
    Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2013·2013-05-22

    Becton Dickinson Recalls Trypticase Soy Agar Media Due to Bacterial Contamination

    Becton Dickinson is recalling Trypticase Soy Agar media because it may be contaminated with bacteria. The recall covers 521,160 pieces distributed worldwide.

    Product
    BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1403-2013·2013-05-22

    Grippo's Potato Chips Recalled for Metal Fragments in Salt Hopper

    Grippo's Cheddar Cheese with a Touch of Jalapeno Potato Chips are being recalled due to metal fragments found in the salt hopper during an inspection.

    Product
    Grippo's CHEDDAR CHEESE WITH A TOUCH OF JALAPENO natural & Artificially Flavored POTATO CHIPS, 1¿¿oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, GRANULAR CHEESE (MILK, CHEESE CULTURES, SALT ENZYMES), MONOSODIUM GLUTAMATE, PARTIALLY HYDROGENATED SOYBEAN AND…
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1292-2013·2013-05-22

    CollaCote Absorbable Collagen Wound Dressing Recalled for Pyrogen Levels

    Integra LifeSciences is recalling CollaCote Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1316-2013·2013-05-22

    Karl Storz Cutting Loops Recalled for Potential Sterile Packaging Damage

    Karl Storz is recalling specific cutting loops due to possible damage to sterile packaging, which may result in airborne contamination.

    Product
    Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1325-2013·2013-05-22

    Varian High Energy Clinacs Radiation Treatment System Recall for Beam Symmetry

    Varian is recalling High Energy Clinacs because photon beams may develop asymmetry, potentially causing minor patient injury or decreased disease control.

    Product
    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2013·2013-05-22

    GE Healthcare Recalls Innova Fluoroscopic Systems Due to Relay Failure

    GE Healthcare is recalling 713 Innova fluoroscopic systems because a relay failure in the power distribution box can cause sudden loss of imaging modes without warning.

    Product
    GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2013·2013-05-22

    Hologic Fluoroscan Mini C-arm InSight Recalled for Inaccurate Irradiation Time Alarms

    Hologic is recalling Fluoroscan Mini C-arm InSight systems because the audible alarm for cumulative irradiation time is inaccurate. This may result in incorrect total irradiation time readings.

    Product
    Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2013·2013-05-22

    Integra Recalls Helistat Absorbable Hemostatic Due to Pyrogen Levels

    Integra LifeSciences is recalling 24,342 boxes of Helistat Absorbable Hemostatic because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2013·2013-05-22

    Integra HeliTape Collagen Wound Dressing Recalled for Pyrogen Levels

    Integra LifeSciences is recalling HeliTape Absorbable Collagen Wound Dressings for dental surgery due to potential pyrogen levels exceeding specifications.

    Product
    HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1401-2013·2013-05-22

    Grippo's Salt & Vinegar Potato Chips Recalled for Metal Fragments

    Grippo Potato Chip Co. is recalling Salt & Vinegar flavored potato chips due to metal fragments found in the salt hopper during an inspection.

    Product
    Grippo's Salt & Vinegar FLAVORED POTATO CHIPS, 1¿oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, LACTOSE, SALT, DEXTROSE, SODIUM DIACETATE, MALIC ACID, AND NOT MORE THAN 2% SILICON DIOXIDE ADDED CONTAINS: MILK***www.grippopotatochips.com GRIPPO POTATO CHIP…
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1281-2013·2013-05-22

    Insight Instruments Recalls M.I.S. Ophthalmic Cannulas Due to Misclassification

    Insight Instruments is recalling 776 M.I.S. Ophthalmic Cannulas distributed in Indiana and Illinois because the device was misclassified.

    Product
    Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas.…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1295-2013·2013-05-22

    HeliPlug Collagen Wound Dressing Recalled for Pyrogen Levels

    Integra LifeSciences is recalling HeliPlug Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1293-2013·2013-05-22

    Integra Recalls CollaPlug Collagen Wound Dressings Due to Pyrogen Levels

    Integra LifeSciences is recalling 155,850 boxes of CollaPlug Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1304-2013·2013-05-22

    Curity Staple Remover Kit Recalled Due to Supplier OTC Drug Issue

    Covidien is recalling Curity Staple Remover Kits because a supplier recalled OTC drug products used in the kits.

    Product
    Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1394-2013·2013-05-22

    Grove Grow Notes Hawthorne Recalled for Unapproved Food Dyes

    S & M International Inc is recalling Grove Grow Notes Hawthorne because it contains unapproved dyes Ponceau 4R and FD&C Yellow #5.

    Product
    Grove Grow Notes Hawthorne , 400 Gram (14 oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Deputy: S&M (USA) Enterprise 4703 2nd Avenue, Brooklyn, NY 11232. Product of China.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1330-2013·2013-05-22

    Bio-Rad Recalls Liquichek ToRCH Plus IgM Control Due to HCV RNA

    Bio-Rad is recalling Liquichek ToRCH Plus IgM Control - Positive because it contains detectable levels of HCV RNA originating from the manufacturing process.

    Product
    Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-1395-2013·2013-05-22

    Tasty Snacks Sour Plum Recalled for Undeclared Sulfites and Unallowed Dye

    S & M International Inc. is recalling Tasty Snacks Sour Plum in New York due to undeclared sulfites, unallowed dye, and undeclared colorant.

    Product
    Tasty Snacks Sour Plum, (6 oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Product of China. Item No. 802578.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1282-2013·2013-05-22

    Integra Recalls DuraGen Dural Graft Matrix Due to Pyrogen Levels

    Integra LifeSciences is recalling DuraGen Dural Graft Matrix because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1334-2013·2013-05-22

    Becton Dickinson Recalls CDC Anaerobe 5% Sheep Blood Agar Due to Contamination

    Becton Dickinson is recalling BBL CDC Anaerobe 5% Sheep Blood Agar because the microbiological media may be contaminated with bacteria.

    Product
    BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F1396-2013·2013-05-22

    Lam Sheng Kee Mini Sausage Recalled for Undeclared Ingredients

    S & M International Inc. is recalling Lam Sheng Kee Mini Sausage Hong Kong Style due to undeclared FD&C Red #40 and minced fish.

    Product
    Lam Sheng Kee Mini Sausage Hong Kong Style, Net Weight 6.3 oz.), Lam Sheng Kee (HK) International Limited, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1333-2013·2013-05-22

    Becton Dickinson Recalls Trypticase Soy Agar and MacConkey II-I Plates

    Becton Dickinson & Co. is recalling specific lots of Trypticase Soy Agar and MacConkey II-I plates due to potential bacterial contamination.

    Product
    BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1313-2013·2013-05-22

    Karl Storz Cutting Loops Recalled for Packaging Damage

    Karl Storz is recalling 9,432 cutting loops due to possible sterile packaging damage that may allow airborne contamination.

    Product
    Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1305-2013·2013-05-22

    Karl Storz Cutting Electrode Recall Due to Packaging Damage

    Karl Storz is recalling cutting electrodes because damaged sterile packaging may allow airborne contamination.

    Product
    Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1387-2013·2013-05-22

    Hokkai Frozen Half Shell Oysters Recalled for Insanitary Conditions

    Hong Chang Corporation is recalling Hokkai Frozen Half Shell Oysters because they were prepared under insanitary conditions, posing a potential health risk.

    Product
    Hokkai Frozen Half Shell Oyster, 144 pcs/case.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1287-2013·2013-05-22

    Integra NeuraGen Nerve Guide Recalled for Pyrogen Deviation

    Integra LifeSciences is recalling NeuraGen Nerve Guides because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-331-2013·2013-05-22

    Glenmark Recalls Topiramate Tablets Due to Off-Odor Complaints

    Glenmark Generics Inc. is recalling Topiramate Tablets due to complaints of a moldy, musty, or fishy odor. The recall covers 9,624 bottles distributed nationwide.

    Product
    TOPIRAMATE — TOPIRAMATE (TOPIRAMATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1319-2013·2013-05-22

    Summit Medical Recalls Myringotomy Lance Blades Due to Incorrect Packaging

    Summit Medical is recalling Myringotomy Lance Blades because the boxes contain the wrong type of blade.

    Product
    Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1329-2013·2013-05-22

    Medtox Diagnostics Recalls PROFILE-V MEDTOXScan Drugs of Abuse Test System

    Medtox Diagnostics is recalling PROFILE-V MEDTOXScan Drugs of Abuse Test Systems due to preliminary screen positive results for cocaine that were not positive on confirmatory testing.

    Product
    PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1308-2013·2013-05-22

    Karl Storz Recalls Sterile Electrodes Due to Packaging Damage

    Karl Storz is recalling 9,432 sterile ball-end electrodes because damaged packaging may allow airborne contamination.

    Product
    Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide

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