The Recall Desk

Archive

May 2013 recalls

607 recalls were announced in May 2013.

What the numbers show

Critical
23
Severe
197
High
166
Moderate
184
Low
37

Of the 607 recalls this month scored against our rubric, 4% are Critical, 32% are Severe.

Which agencies issued them

201–300 of 607

  • 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-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
  • SevereFDA (Drugs)·D-355-2013·2013-05-22

    Green Valley Drugs Recalls Cyanocobalamin Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 6,292 vials of Cyanocobalamin Injection nationwide because the pharmacy could not ensure the products were sterile.

    Product
    Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin 1000mcg, b) Cyanocobalamin 1000 mcg/mL in 1 mL, 10 mL, and 30 mL and 1 mL Preservative Free, 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 (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-358-2013·2013-05-22

    Green Valley Drugs Recalls Dexpanthenol Injection Due to Sterility Concerns

    Green Valley Drugs is recalling 273 vials of Dexpanthenol Injection nationwide due to a lack of assurance of sterility and quality control concerns.

    Product
    Dexpanthenol Injection, all strengths and all presentations including Dexpanthenol 250 mg/30 mL; Dexpanthenol 250 mg/mL 10 mL, 30 mL, 50 mL; and Dexpanthenol 250 mg/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-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-343-2013·2013-05-22

    Green Valley Drugs Recalls Betamethasone Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Betamethasone Acetate and Betamethasone Sodium Injection because the pharmacy lacked assurance of sterility in its quality control processes.

    Product
    Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-363-2013·2013-05-22

    Green Valley Drugs Recalls ED Mix Injections Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling 10,684 vials of ED Mix Injections nationwide due to a lack of assurance of sterility in compounded products.

    Product
    ED Mix Injections, all strengths and all presentations including a) ED mix TM -at 2, b) ED-Mix BI-Mix 10 30 mL, c) ED-Mix BI-Mix 9 30 mL; d) ED-Mix BI-Mix-3-30, e) ED-Mix PGE 80-30, f) ED-Mix SB4 30 mL, g) Ed-Mix ST 9E, h) ED-Mix ST-1, i) ED-MIX T106, j) ED-MIX-PGE-150 30 mL, k)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-405-2013·2013-05-22

    Green Valley Drugs Recalls Sodium Bicarbonate and Lidocaine Injection

    Green Valley Drugs is recalling 335 vials of Sodium Bicarbonate and Lidocaine Injection due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Sodium Bicarbonate and Lidocaine Injection, all strengths and all presentations including Sod-Bicarb-Lido-0.27-2.73-3 syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-349-2013·2013-05-22

    FDA Recalls Betamethasone Injection Due to Sterility Assurance Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling Betamethasone Combination with Lidocaine and Bupivacaine Injection due to lack of assurance of sterility.

    Product
    Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection, all strengths and all presentations including a) Betameth combo 6 mg/mL lido 1% bup 0.5% syr; and b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #18
    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 free
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-382-2013·2013-05-22

    Green Valley Drugs Recalls L-Lysine Injection Due to Sterility Concerns

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

    Product
    L-Lysine Injection, all strengths and all presentations including a) L-Lysine_100-30 mL, b) L-Lysine_100 mg/30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-383-2013·2013-05-22

    Green Valley Drugs Recalls Magnesium Chloride Injection Due to Sterility Concerns

    Green Valley Drugs is recalling 197 vials of Magnesium Chloride Injection nationwide due to a lack of assurance of sterility and quality control concerns.

    Product
    Magnesium Chloride Injection, all strengths and all presentations including a) Magnesium Chloride 200 mg/50 mL and b) Magnesium Chloride 200 mg/mL 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-359-2013·2013-05-22

    Green Valley Drugs Recalls DMPS Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 251 vials of DMPS Injection nationwide due to a lack of assurance of sterility and quality control concerns.

    Product
    Dimercapto-propane-sulfonic acid (DMPS) Injection, all strengths and all presentations including a) DMPS 50 mg/5 mL, b) DMPS 50 mg/mL PF 5 mL, c) DMPS Acid 250 mg/5 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 p
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-356-2013·2013-05-22

    Green Valley Drugs Recalls Cyclosporine Injection Due to Sterility Concerns

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

    Product
    Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2% Aqueous Solution 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-394-2013·2013-05-22

    Green Valley Drugs Recalls Metoprolol Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling 65 vials of Metoprolol Injection due to lack of assurance of sterility and quality control concerns.

    Product
    Metoprolol Injection, all strengths and all presentations including Metoprolol 1 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-366-2013·2013-05-22

    Green Valley Drugs Recalls Folic Acid Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 244 vials of Folic Acid Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Folic Acid Injection, all strengths and all presentations including a) Folic Acid 10 mg/mL 30 mL; b) Folic Acid PF 10 mg/mL 2 mL and 5 mL; c) Folic Acid 20 mg/mL 30 mL; d) Folic Acid 5 mg/mL 5 mL, 10 ml and 30 mL Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV
    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 (Drugs)·D-332-2013·2013-05-22

    FDA Recalls Libigrow Capsules for Undeclared Active Ingredients

    Performance Plus Marketing, Inc. is recalling Libigrow capsules marketed without FDA approval. The product may contain undeclared sildenafil, tadalafil, and analogues.

    Product
    libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-413-2013·2013-05-22

    Green Valley Drugs Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Testosterone Cypionate Injection vials and syringes because the compounding pharmacy could not ensure the products were sterile.

    Product
    Testosterone Cypionate Injection, all strengths and all presentations including a) Testosterone Cyp 200 mg/10 mL; b) Testosterone Cypionate 100 mg/10mL; c) Testosterone Cypionate 200 mg 10 mL; d) Testosterone Cypionate 200 mg 30 mL; e) Testosterone Cypionate 200 mg/mL; f) Testo
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-327-2013·2013-05-22

    Evol Nutrition Recalls Mojo Nights Capsules for Unapproved Ingredients

    Evol Nutrition is recalling Mojo Nights capsules because they contain unapproved ingredients used to treat erectile dysfunction.

    Product
    Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351
    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 (Drugs)·D-410-2013·2013-05-22

    Green Valley Drugs Recalls Testosterone Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 51 vials of Testosterone Cypionate and Testosterone Propionate Injection due to lack of assurance of sterility.

    Product
    Testosterone Cypionate and Testosterone Propionate Injection, all strengths and all presentations including a) Testosterone cyp 200/test prop 20 mg 10 mL and b) Testosterone Cyp 200 mg/Test Prop 50 mg 10mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 8901
    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-389-2013·2013-05-22

    Green Valley Drugs Recalls Methylprednisolone and Dexamethasone Injections for Sterility Concerns

    Green Valley Drugs is recalling Methylprednisolone and Dexamethasone Injections due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Methylprednisolone and Dexamethasone Injection, all strengths and all presentations including a) Methylpred/ Dexameth 1-2-3 mL and b) Methylpred/Dexa 3 mL PFS; 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 (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 1500u/1.5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-347-2013·2013-05-22

    Green Valley Drugs Recalls BET-ACE-LIDO-6-2 Injection Due to Sterility Concerns

    Green Valley Drugs is recalling BET-ACE-LIDO-6-2 Injection products because the pharmacy could not ensure the sterility of the compounded items.

    Product
    BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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 (Food)·F-1390-2013·2013-05-22

    Hong Chang Recalls Hokkai Oyster Meat Due to Insanitary Conditions

    Hong Chang Corporation is recalling Hokkai Large Size Oyster Meat because it was prepared under insanitary conditions that may have rendered it injurious to health.

    Product
    Hokkai Large Size Oyster Meat I.Q.F., 1 lb x 20, 3 lbs x 8, 1 lb x 30.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-345-2013·2013-05-22

    Green Valley Drugs Recalls B-Complex Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 679 vials of B-Complex Injection products nationwide due to a lack of assurance of sterility and quality control concerns.

    Product
    B-Complex Injection, all strengths and all presentations including a) B-Complex Injection 30 mL; b) B-Complex PF 2 mL; c) B-Complex Plus-100; d) B-Complex_B12_30 mL; e) B-Complex-50-Methyl-30-Lido 30 mL; f) B-CompSuper-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-415-2013·2013-05-22

    Green Valley Drugs Recalls Triamcinolone Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 1,423 vials of Triamcinolone Injection nationwide due to a lack of assurance of sterility and quality control concerns.

    Product
    Triamcinolone Injection, all strengths and all presentations including a) Triamcinolone 40 mg/1 mL PF, b) Triamcinolone Acetonide 45 mg/mL, c) Triamcinolone 50 mg/mL 5 mL PF, d) Triamcinolone 45 mg/mL10 mL, 30 mL, e) Triamcinolone 40 mg/mL SDV PF 1 mL, 2 mL, Rx only, Green Valley
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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: 1,410cs/60/1
    Category
    Food
    Distribution
    6 states
  • 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, CARM
    Category
    Food
    Distribution
    6 states
  • 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 ARTIFICIA
    Category
    Food
    Distribution
    6 states
  • HighFDA (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
  • 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 C
    Category
    Food
    Distribution
    6 states
  • 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-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 conditio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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. Topical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 provides
    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 single
    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
  • 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
    AMERICAN COACH — AMERICAN COACH, FLEETWOOD AMERICAN REVOLUTION, DISCOVERY, EXPEDITION, BOUNDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1382-2013·2013-05-22

    Carson's Fudge Brownie Cookies Recalled for Undeclared Allergens

    Carson's Country Market is recalling Fudge Brownie Cookies due to undeclared walnuts, wheat, and soy. Consumers with allergies should not eat the product.

    Product
    CARSON'S HOMEMADE PIES AND OTHER GOOD THINGS brand FUDGE BROWNIE COOKIES, NET WT. 14 OZ., UPC 7 53182 15240 0 --- Corner Rt 31 + Rt 93, Lockport, NY 14094 - 716-433-2248 (phone) --- The cookies are packaged in clear, hard plastic containers with seven or eight cookies per contain
    Category
    Food
    Distribution
    1 state
  • 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 imp
    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 CO
    Category
    Food
    Distribution
    6 states
  • 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 (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-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 (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-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. Topica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 use,
    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 (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 pla
    Category
    Food
    Distribution
    1 state
  • 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 (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-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 applica
    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-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 (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 (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-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 a
    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 (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 (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-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 (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 (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 (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
  • 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
  • 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 (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
  • 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 (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-1306-2013·2013-05-22

    Karl Storz Cutting Electrode Recall Due to Packaging Damage

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

    Product
    Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    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-1310-2013·2013-05-22

    Karl Storz Recalls Sterile Electrode Accessories Due to Packaging Damage

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

    Product
    Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    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 (Devices)·Z-1328-2013·2013-05-22

    Iris Diagnostics Recalls iQ Control/Focus Sets Due to Performance Issues

    Iris Diagnostics is recalling iQ Control/Focus Sets because customer complaints indicated the product failed to meet performance specifications, preventing patient sample testing.

    Product
    Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
    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
  • 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-1315-2013·2013-05-22

    Karl Storz Cutting Electrodes Recalled for Packaging Damage

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

    Product
    Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    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-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 (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 (Drugs)·D-418-2013·2013-05-22

    Hi-Tech Pharmacal Recalls Subpotent Bucalsep Oral Solution

    Hi-Tech Pharmacal Co., Inc. is recalling 10,440 bottles of Bucalsep Oral Solution because the cetylpyridinium chloride ingredient is subpotent.

    Product
    BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manufactured for GIL PHARMACEUTICAL CORP, PONCE, PUERTO RICO 00717-1565 -- NDC 58552-103-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1309-2013·2013-05-22

    Karl Storz Recalls Roller Ball Electrodes Due to Packaging Damage

    Karl Storz is recalling 9,432 Roller Ball Electrodes because damaged sterile packaging may allow airborne contamination.

    Product
    Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1314-2013·2013-05-22

    Karl Storz Recalls Cold Straight Knives Due to Packaging Damage

    Karl Storz is recalling 9,432 units of cold straight knives because damaged sterile packaging may allow airborne contamination.

    Product
    Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    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-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 (Drugs)·D-319-2013·2013-05-22

    Walmart Amlodipine Tablets Recalled for Labeling Error

    Legacy Pharmaceutical Packaging is recalling Walmart Amlodipine Besylate Tablets 10 mg due to a label error listing 5 mg in the USP description.

    Product
    Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. Packaged by: Legacy Pharmac
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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. The
    Category
    Medical Device
    Distribution
    2 states

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