The Recall Desk

Archive

July 2016 recalls

921 recalls were announced in July 2016.

What the numbers show

Critical
82
Severe
382
High
263
Moderate
177
Low
17

Of the 921 recalls this month scored against our rubric, 9% are Critical, 41% are Severe.

601–700 of 921

  • CriticalFDA (Food)·F-1627-2016·2016-07-13

    Wegmans Recalls Frozen Round Brownies Due to Undeclared Milk Allergen

    Wegmans Food Markets is recalling Frozen Round Brownies because they contain an undeclared milk allergen. The product is a component used in other items and was distributed in six states.

    Product
    Frozen Round Brownie CC#016969 - is not a retail item but instead is a component to the other items.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1661-2016·2016-07-13

    Pictsweet Vegetables for Cajun Gumbo Recalled for Listeria Risk

    The Pictsweet Company is recalling Vegetables for Cajun Gumbo because the onions used in the product may be contaminated with Listeria monocytogenes.

    Product
    PICTSWEET(R) Vegetables for Cajun Gumbo, Seasoned with a blend of Cajun Spices, NET WT 12 OZ (340g), UPC 70560 95818, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1621-2016·2016-07-13

    Wegmans Brownies Recalled for Undeclared Milk Allergen

    Wegmans is recalling Fudgy & Chewy Brownies with Chocolate Chips due to an undeclared milk allergen. The product was distributed in six states.

    Product
    Wegmans Fudgy & Chewy Brownies with Chocolate Chips 14 oz., UPC#7789032990
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1657-2016·2016-07-13

    Kroger Vegetable Stir Fry Starters Recalled for Listeria Risk

    The Pictsweet Company is recalling Kroger Vegetable Stir Fry Starters because the onions used in the product may be contaminated with Listeria monocytogenes.

    Product
    Kroger(R) VEGETABLES WITH NOODLES, egg noodles, broccoli, carrots, green bell peppers, mushrooms, onions & red bell peppers, STIR FRY STARTERS(R), NET WT 12 OZ (340g), UPC 11110 89776, DISTRIBUTED BY THE KROGER COMPANY, CINCINNATI, OH 45202
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1165-2016·2016-07-13

    FDA Recalls Zero Xtreme Fat Burner for Unapproved Ingredients

    The FDA is recalling Zero Xtreme High Performance Fat Burner capsules because testing found unapproved ingredients. Consumers should stop using the product.

    Product
    Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1146-2016·2016-07-13

    FDA Recalls SlimeX-15 Capsules Containing Undeclared Sibutramine

    The FDA is recalling SlimeX-15 Capsules because they contain undeclared sibutramine, a withdrawn drug. Consumers should stop using the product.

    Product
    SlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceuticals Ltd. MUMBAI-400-030 Manufactured in India by: HAB Pharmaceuticals & Research Limited 10-Pharma City, SIDCUL, Selaqui, Dehradun, 248 197
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1151-2016·2016-07-13

    ZI XIU TANG Beauty Capsules Recalled for Undeclared Sibutramine

    Bee Extremely Amazed LLC is recalling ZI XIU TANG Beauty Face & Figure Capsules because they contain undeclared sibutramine, a withdrawn drug.

    Product
    ZI XIU TANG BEAUTY FACE & FIGURE Capsules, 250 mg, 60-count bottles
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1654-2016·2016-07-13

    Harris Teeter Soup Mix Recalled for Listeria Risk

    The Pictsweet Company is recalling Harris Teeter brand Soup Mix Veggies due to the possibility of Listeria monocytogenes contamination in the onions.

    Product
    Harris Teeter(TM) brand SOUP MIX VEGGIES, carrots, potatoes, corn, green beans, lima beans, okra, green peas, celery, onions, NET WT 12 OZ (340g), UPC 72036 71683, PROUDLY DISTRIBUTED BY HARRIS TEETER, LLC, MATTHEWS, NC 28105
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1143-2016·2016-07-13

    La' Trim Plus Capsules Recalled for Undeclared Withdrawn Ingredients

    Bee Extremely Amazed LLC is recalling La' Trim Plus Capsules because the product contains undeclared sibutramine and phenolphthalein, both withdrawn from the US market for safety reasons.

    Product
    La' Trim Plus Capsules, 350 mg, 60-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando, FL 32801 (407) 930-4043
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1149-2016·2016-07-13

    XCEL Capsules Recalled for Undeclared Fluoxetine and Phenolphthalein

    Bee Extremely Amazed LLC is recalling XCEL Capsules marketed as a dietary supplement because they contain undeclared fluoxetine and phenolphthalein.

    Product
    XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1150-2016·2016-07-13

    XCEL Advanced Capsules Recalled for Undeclared Phenolphthalein

    Bee Extremely Amazed LLC is recalling XCEL Advanced Capsules because they contain undeclared phenolphthalein, a withdrawn ingredient with carcinogenic concerns.

    Product
    XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1137-2016·2016-07-13

    Hospira Recalls Magnesium Sulfate Injection Due to Particulate Matter

    Hospira Inc. is recalling specific lots of Magnesium Sulfate Injection due to confirmed particulate matter. The recall covers 88,500 vials distributed in the US and several Middle Eastern countries.

    Product
    Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1141-2016·2016-07-13

    Bee Extremely Amazed LLC Recalls Infinity Capsules Tainted With Sibutramine

    Bee Extremely Amazed LLC is recalling Infinity Capsules because the product was found to contain undeclared sibutramine, a withdrawn appetite suppressant.

    Product
    Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1138-2016·2016-07-13

    Asset BOLD Capsules Recalled for Undeclared Sibutramine and Phenolphthalein

    Bee Extremely Amazed LLC is recalling Asset BOLD Capsules because they contain undeclared sibutramine and phenolphthalein, making them unapproved drugs.

    Product
    Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1622-2016·2016-07-13

    Wegmans Brownies Recalled for Undeclared Milk Allergen

    Wegmans is recalling Fudgy & Chewy Brownies with Walnuts due to an undeclared milk allergen. The product was sold in six states.

    Product
    Wegmans Fudgy & Chewy Brownies with Walnuts 14 oz., UPC#7789075773
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Drugs)·D-1158-2016·2016-07-13

    Cantrell Drug Recalls Subpotent Fentanyl Citrate Syringes Nationwide

    Cantrell Drug Company is recalling 1,652 syringes of fentanyl citrate because the medication was subpotent. The recall is voluntary and nationwide.

    Product
    fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-074-16, UPC: 0100352533074165
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1164-2016·2016-07-13

    Cantrell Drug Recalls Subpotent Midazolam Injection Syringes Nationwide

    Cantrell Drug Company is recalling 1,570 syringes of Midazolam HCl injection because the drug was found to be subpotent. The recall is voluntary and nationwide.

    Product
    MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-001-16 UPC: 0100352533001161
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1662-2016·2016-07-13

    Pictsweet Gumbo Vegetables Recalled for Listeria Risk

    The Pictsweet Company is recalling Pictsweet Gumbo Vegetables because the onions used in the product were recalled for possible Listeria monocytogenes contamination.

    Product
    PICTSWEET(R) Gumbo Vegetables, NET WT 12 OZ (340g), UPC 70560 95995, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1152-2016·2016-07-13

    Cantrell Drug Recalls Subpotent Fentanyl Citrate Injection Syringes

    Cantrell Drug Company is recalling 884 syringes of fentanyl citrate injection because the drug was subpotent. The recall is voluntary and nationwide.

    Product
    fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-024-45, UPC: 0100352533024450
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1092-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Minocycline Products Due to Processing Controls

    Reliable Compounding Pharmacy is recalling all minocycline products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All minocycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1068-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Biotin Capsules Due to Labeling Error

    Reliable Compounding Pharmacy is recalling Biotin 100 mg capsules because they were found to contain 4-aminopyridine instead of the labeled ingredient.

    Product
    CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Food)·F-1653-2016·2016-07-13

    Pictsweet Recalls Frozen Pepper and Onion Blends for Listeria Risk

    The Pictsweet Company is recalling frozen three pepper and onion blends sold under Harris Teeter, Kroger, and Pictsweet brands due to potential Listeria monocytogenes contamination.

    Product
    Frozen three pepper and onion blends labeled as: a) Harris Teeter(TM) brand THREE PEPPER & ONION BLEND, NET WT 12 OZ (340g), UPC 72036 71681, PROUDLY DISTRIBUTED BY HARRIS TEETER, LLC, MATTHEWS, NC 28105 b) Kroger(R) 3 PEPPER & ONION BLEND, onions, green bell peppers, yello
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1156-2016·2016-07-13

    Cantrell Drug Recalls Subpotent Fentanyl Citrate Injection Syringes

    Cantrell Drug Company is recalling fentanyl citrate injection syringes because they contain less active drug than labeled.

    Product
    fentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in a) 1 mL syringe (NDC 52533-214-45, UPC: 0100352533214455) and b) 3 mL syringe (NDC 52533-214-60, UPC: 0100352533214608), Rx Only, Cantrell Drug Co., Little Rock, AR
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1166-2016·2016-07-13

    Vital Care Compounder Recalls Testosterone Cypionate Due to Sterility Concerns

    Vital Care Compounder is recalling 13 units of Testosterone Cypionate 200mg/ml because aluminum crimps may not fully seal the vials, compromising sterility.

    Product
    TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1153-2016·2016-07-13

    Cantrell Recalls Subpotent Atropine Sulfate Injection Syringes Nationwide

    Cantrell Drug Company is recalling specific lots of Atropine Sulfate Injection Solution because the drug was found to be subpotent.

    Product
    Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syringes and b) 2 mL syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-010-45, UPC: 0100352533010453
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1613-2016·2016-07-13

    Sid Wainer Tart Shells Recalled for Undeclared Egg Allergen

    Sid Wainer and Son is recalling Domaine de Provence La Cucina Tart Shells because the product contains undeclared eggs, a major food allergen.

    Product
    Domaine de Provence La Cucina Tart Shells Produced Exclusively for Sid Wainer& Son, New Bedford, MA UPC Code: 708152149119 Item Number: 149110
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Food)·F-1616-2016·2016-07-13

    Norpac Recalls Organic Green Peas for Listeria Contamination Risk

    Norpac Foods is recalling Natural Directions Organic Green Peas due to potential Listeria monocytogenes contamination. The product was distributed in nine states and Guam.

    Product
    Natural Directions Organic Green Peas, frozen, net wt. 12 oz. UPC 0 15400 19670 3
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Drugs)·D-1161-2016·2016-07-13

    Cantrell Drug Recalls Subpotent Lidocaine HCl Injection Syringes

    Cantrell Drug Company is recalling 450 syringes of Lidocaine HCl 1% injection due to subpotent drug levels. The recall is voluntary and nationwide.

    Product
    LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992033
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2122-2016·2016-07-13

    Medtronic Recalls Cytosponge Cell Collection Kits Due to Detachment Reports

    Medtronic is recalling Cytosponge Cell Collection Kits after two reports of the device detaching from the removal string during withdrawal from the esophagus.

    Product
    Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophag
    Category
    Medical Device
    Distribution
    7 states
  • SevereUSDA FSIS·059-2016·2016-07-13

    Michael Angelo's Recalls Frozen Shrimp Scampi for Undeclared Allergens

    Michael Angelo's Gourmet Foods is recalling frozen shrimp scampi products that may contain undeclared chicken, egg, and soy due to a packaging error.

    Product
    Michael Angelo's Gourmet Foods Inc. — Michael Angelo's Gourmet Foods, Inc. Recalls Shrimp Scampi Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1664-2016·2016-07-13

    Pictsweet Deluxe Stir-Fry Vegetables Recalled for Listeria Risk

    The Pictsweet Company is recalling Deluxe Stir-Fry Chinese Style Vegetables because they contain onions that may be contaminated with Listeria monocytogenes.

    Product
    PICTSWEET(R) Deluxe Stir-Fry Chinese Style Vegetables, Oriental Seasoning, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 70560 95689, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1102-2016·2016-07-13

    Reliable Drug Recalls Triamcinolone Products Due to Processing Control Deficiencies

    Reliable Drug/Reliable Compounding Pharmacy is recalling all triamcinolone products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All triamcinolone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Food)·F-1615-2016·2016-07-13

    Norpac Organic Mixed Vegetables Recalled for Listeria Risk

    Norpac Foods is recalling 1,850 cases of Natural Directions Organic Mixed Vegetables due to potential Listeria monocytogenes contamination.

    Product
    Natural Directions Organic Mixed Vegetables, frozen, net wt. 12 oz. UPC 0 15400 19672 7
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-1658-2016·2016-07-13

    Kroger Stir Fry Starters Recalled for Possible Listeria Contamination

    The Pictsweet Company is recalling Kroger Stir Fry Starters because the onions included may be contaminated with Listeria monocytogenes.

    Product
    Kroger(R) VEGETABLES, broccoli, sugar snap peas, green bean carrots, celery, onions, mushrooms, & red bell peppers, STIR FRY STARTERS(R), NET WT 12 OZ (340g), UPC 11110 89775, DISTRIBUTED BY THE KROGER COMPANY, CINCINNATI, OH 45202
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1155-2016·2016-07-13

    Cantrell Drug Recalls Subpotent Fentanyl Citrate Injection Syringes

    Cantrell Drug Company is recalling 235 syringes of fentanyl citrate injection because the drug was subpotent. The recall is voluntary and nationwide.

    Product
    fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock AR --- UPC: 9999993301
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1660-2016·2016-07-13

    Pictsweet Frozen Seasoning Blend Recalled for Listeria Risk

    The Pictsweet Company is recalling specific lots of frozen seasoning blends due to potential Listeria monocytogenes contamination in the onion ingredients.

    Product
    Frozen seasoning blend labeled as: a) PICTSWEET(R) Seasoning Blend, recipe helper, NET WT 10 OZ (283g), UPC 70560 96902, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006 b) PICTSWEET(R) Seasoning Blend, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 70560 96911, DISTRIBUTED BY THE
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1663-2016·2016-07-13

    Pictsweet Steam'ables Summer Vegetables Recalled for Listeria Risk

    The Pictsweet Company is recalling Steam'ables Seasoned Summer Vegetables because they contain onions that may be contaminated with Listeria monocytogenes.

    Product
    PICTSWEET(R) Steam'ables, Seasoned Summer Vegetables, with Cracked Pepper Seasoning, NET WT 10 OZ (283g), UPC 70560 98001, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1103-2016·2016-07-13

    Reliable Drug Recalls Compounded Lidocaine, Meloxicam, Diclofenac, and Baclofen

    Reliable Drug is recalling compounded lidocaine, meloxicam, diclofenac, and baclofen products due to a lack of processing controls.

    Product
    All lidocaine, meloxicam, diclofenac and baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1066-2016·2016-07-13

    QuVa Pharma Recalls Phenylephrine Syringes Due to Labeling Error

    QuVa Pharma is recalling 20 cases of Phenylephrine syringes because some units have incorrect strength labels on the protective overwrap.

    Product
    PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only, Healix Infusion Therapy Inc, 1075 W Park One Drive, Suite 200, Sugar Land Texas 77478, Product Code: 75901-1205-35.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1162-2016·2016-07-13

    Cantrell Drug Recalls Subpotent Midazolam HCl Injection Syringes

    Cantrell Drug Company is recalling 3,853 syringes of Midazolam HCl injection because the drug was subpotent. The recall is voluntary and nationwide.

    Product
    Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --- NDC 52533-157-45, UPC: 0100352533157455
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1131-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls All Compounded Tacrolimus Products

    Reliable Compounding Pharmacy is recalling all compounded tacrolimus products due to a lack of processing controls. The recall covers products distributed in California, Hawaii, and New Mexico.

    Product
    All tacrolimus Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-2131-2016·2016-07-13

    GE Healthcare Recalls Discovery MR750w MRI Scanners Due to Burn Risk

    GE Healthcare is recalling 471 Discovery MR750w MRI scanners because a small area of the patient bore can become warm enough to cause a serious burn if proper padding is not used.

    Product
    GE Healthcare, Discovery MR750w
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-1614-2016·2016-07-13

    Sid Wainer & Son Recalls Tart Shells for Undeclared Coconut Allergen

    Sid Wainer & Son is recalling Domaine de Provence Neutral 3" Cone Tart Shells because they contain undeclared coconut, a major food allergen.

    Product
    Domaine de Provence Neutral 3"¿ Cone Tart Shells Produced Exclusively for Sid Wainer & Son, New Bedford, MA UPC Code: 708152316856 Item Number: 316850
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1603-2016·2016-07-13

    Grain Craft Graham Recalled for Possible Peanut Protein Contamination

    Grain Craft is recalling 50-pound bags of Graham due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Graham, Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1598-2016·2016-07-13

    Grain Craft Cake Flour Recalled for Possible Peanut Contamination

    Grain Craft is recalling 50-pound bags of Craft Cake Flour due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Craft Cake Flour (M4138), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1605-2016·2016-07-13

    Grain Craft Pastry Flour Recalled for Possible Peanut Protein Contamination

    Grain Craft, Inc. is recalling specific lots of 50-lb pastry flour due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Pastry Flour (BRMOO20, M1633, 825, R000110690), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1655-2016·2016-07-13

    Pictsweet Recalls Frozen Chopped Onions for Listeria Risk

    The Pictsweet Company is recalling specific lots of frozen chopped onions due to possible Listeria monocytogenes contamination. The recall affects Kroger and Pictsweet brands distributed nationwide.

    Product
    Frozen chopped onions labeled as: a) Kroger(R) CHOPPED ONIONS, RECIPE BEGINNINGS(R), NET WT 12 OZ (340g), UPC 11110 89791, DISTRIBUTED BY THE KROGER COMPANY, CINCINNATI, OH 45202 b) PICTSWEET(R) Chopped Onions, recipe helper, NET WT 10 OZ (283g), UPC 70560 96609, DISTRIBUTE
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1629-2016·2016-07-13

    Way Fong Recalls Fried Shrimp Flavoured Fish Bar for Undeclared Egg Allergen

    Way Fong LLC is recalling 15 cases of Fried Shrimp Flavoured Fish Bar in New York due to the presence of undeclared egg allergen.

    Product
    FRIED SHRIMP FLAVOURED FISH BAR, Net Wt 9.07 Kg 4 X 5 lbs. bulk, Product of Canada, KEEP REFRIGERATED
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1097-2016·2016-07-13

    Reliable Drug Recalls Compounded Hydrocortisone Products Due to Processing Controls

    Reliable Drug is recalling all compounded hydrocortisone products due to a lack of processing controls. The recall covers products distributed in California, Hawaii, and New Mexico.

    Product
    All hydrocortisone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-2130-2016·2016-07-13

    Custom Ultrasonics System 83 Plus Endoscope Washer Recall Issued

    Custom Ultrasonics is recalling System 83 Plus endoscope washer/disinfectors to warn customers not to use them for duodenoscopes until further notice.

    Product
    The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2016·2016-07-13

    Karl Storz Image1 SPIES X-LINK Camera Control Unit Recall

    Karl Storz Endoscopy is recalling Image1 SPIES X-LINK Camera Control Units due to potential electrical interference when used with specific camera heads and mediastinoscopes.

    Product
    Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-2129-2016·2016-07-13

    Medtronic PoleStar MRI System Components Recalled for Electrical Shock Risk

    Medtronic Navigation is recalling PoleStar MRI system components due to misplaced ground pins that may cause electrical shock to users.

    Product
    PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging device to produce MRI images of sections of the head selected by the physician.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1604-2016·2016-07-13

    Grain Craft Unenriched Pastry Flour Recalled for Possible Peanut Contamination

    Grain Craft, Inc. is recalling specific lots of Unenriched Pastry Flour due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Unenriched Pastry Flour, (M1613, R100258001), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-1118-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Diltiazem Products Due to Processing Controls

    Reliable Compounding Pharmacy is recalling all diltiazem products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All diltiazem Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-2082-2016·2016-07-13

    Medtronic 0-arm Imaging mobile x-ray system recall for battery damage risk

    Medtronic is recalling 0-arm Imaging mobile x-ray systems because replacement batteries may be damaged during shipment, creating a risk of failure.

    Product
    Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1599-2016·2016-07-13

    Grain Craft Recalls Kraft Cake Flour Due to Possible Peanut Contamination

    Grain Craft, Inc. is recalling 50-pound bags of Kraft Cake Flour due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Kraft Cake Flour (110760), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1602-2016·2016-07-13

    Grain Craft Donut Flour Recalled for Possible Peanut Protein Contamination

    Grain Craft, Inc. is recalling Donut Flour due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Donut Flour, Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1659-2016·2016-07-13

    Pictsweet Steamables Spring Vegetables Recalled for Listeria Risk

    The Pictsweet Company is recalling Pictsweet Steamables Seasoned Spring Vegetables because the onions used in the product were recalled for possible Listeria monocytogenes contamination.

    Product
    PICTSWEET(R) Steamables, Seasoned Spring Vegetables, with Asparagus and Ground Peppercorn Seasoning, NET WT 10 OZ (283g), UPC 70560 97826, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1600-2016·2016-07-13

    Kraft Cake Flour Recalled for Possible Peanut Protein Contamination

    Grain Craft, Inc. is recalling 50 lb. bags of Kraft Cake Flour due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Kraft Cake Flour (110760), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2125-2016·2016-07-13

    Medtronic Recalls MyCareLink Patient Monitor Due to Data Transmission Failure

    Medtronic is recalling 262 MyCareLink Patient Monitors because a software update prevents implanted device data from reaching clinicians, despite appearing successful to patients.

    Product
    Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2124-2016·2016-07-13

    Esaote G-scan Brio MRI System Recalled for Table Fracture Risk

    Esaote S.p.A. is recalling G-scan Brio MRI systems because dynamic loading forces from larger patients can fracture the patient table's extremity portion.

    Product
    Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2123-2016·2016-07-13

    Medtronic Recalls Cytosponge Cell Collection Device Due to Detachment Reports

    Medtronic is recalling the Cytosponge Cell Collection Device after two reports of the device detaching from its removal string during withdrawal from the esophagus.

    Product
    Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-1623-2016·2016-07-13

    Wegmans Brownie with Icing and Walnuts Recalled for Undeclared Milk

    Wegmans is recalling 51 units of Brownie with Icing and Walnuts due to an undeclared milk allergen. The product was sold in six states.

    Product
    Wegmans Brownie with Icing and Walnuts, Pan, 16 oz., UPC#7789037092
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2135-2016·2016-07-13

    Toshiba Vantage Titan 3T MRI System Recalled for Gradient Coil Issue

    Toshiba American Medical Systems is recalling 33 Vantage Titan 3T MRI systems due to a potential problem with the gradient coil.

    Product
    MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the featur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1601-2016·2016-07-13

    Grain Craft Recalls Bojangles Chicken Breading Flour for Peanut Contamination

    Grain Craft, Inc. is recalling Bojangles Chicken Breading Flour due to possible peanut protein contamination. The product was distributed to nine states.

    Product
    Bojangles Chicken Breading Flour (12248), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2120-2016·2016-07-13

    ZYTO Technologies Recalls ZYTO Tower and Software for Regulatory Violations

    ZYTO Technologies is voluntarily recalling ZYTO Tower devices and software because their marketing claims exceeded the scope of their FDA 510(k) clearance.

    Product
    The ZYTO Tower is the input device to program the software with various virtual items.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1127-2016·2016-07-13

    Reliable Drug Recalls Methyltestosterone Products Due to Processing Control Issues

    Reliable Drug is recalling all methyltestosterone products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All methyltestosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1128-2016·2016-07-13

    Reliable Drug Recalls Clobetasol Products Due to Processing Control Deficiencies

    Reliable Drug is recalling all clobetasol products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All clobetasol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1111-2016·2016-07-13

    Reliable Drug Recalls Compounded Retinoic Acid Products Due to Processing Controls

    Reliable Drug is recalling all compounded retinoic acid products due to a lack of processing controls. The products were distributed in California, Hawaii, and New Mexico.

    Product
    All retinoic acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1063-2016·2016-07-13

    Dr. Reddy's Recalls Sirolimus Tablets Due to Impurity

    Dr. Reddy's Laboratories is recalling specific lots of Sirolimus tablets because they failed impurity specifications for secorapamycin.

    Product
    SIROLIMUS — SIROLIMUS (SIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1091-2016·2016-07-13

    Reliable Drug Recalls Fluoxymesterone Products Due to Processing Control Deficiencies

    Reliable Drug is recalling all fluoxymesterone products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All fluoxymesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1123-2016·2016-07-13

    Reliable Drug Recalls Compounded Doxycycline Products Due to Processing Controls

    Reliable Drug is recalling all compounded doxycycline products due to a lack of processing controls. The recall covers products distributed in California, Hawaii, and New Mexico.

    Product
    All doxycycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1085-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls All Arginine Products Due to Processing Controls

    Reliable Rexall-A Compounding Pharmacy is recalling all arginine products due to a lack of processing controls. The recall affects products distributed in California, Hawaii, and New Mexico.

    Product
    All arginine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1126-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Ketamine and Amitriptyline Due to Processing Controls

    Reliable Compounding Pharmacy is recalling all ketamine and amitriptyline products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All ketamine and amitriptyline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1087-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Budesonide Products Due to Processing Control Issues

    Reliable Compounding Pharmacy is recalling all budesonide products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All budesonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1104-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls All Compounded Thyroid Products

    Reliable Rexall-A Compounding Pharmacy is recalling all compounded thyroid products due to a lack of processing controls.

    Product
    All thyroid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1121-2016·2016-07-13

    Reliable Drug Recalls Fluconazole Products Due to Processing Control Issues

    Reliable Drug is recalling all fluconazole products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All fluconazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1096-2016·2016-07-13

    Reliable Drug Recalls Jack Newman Cream Products Due to Processing Controls

    Reliable Drug is recalling all Jack Newman Cream Products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All Jack Newman Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1071-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls All TRIE Products Due to Processing Controls

    Reliable Compounding Pharmacy is recalling all TRIE products because of a lack of processing controls. The recall covers lots compounded between March 24, 2015, and March 24, 2016.

    Product
    All TRIE Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1078-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Fluocinonide Products Due to Processing Controls

    Reliable Rexall-A Compounding Pharmacy is recalling all fluocinonide products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All fluocinonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1112-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Coal Tar Products Due to Processing Controls

    Reliable Compounding Pharmacy is recalling all coal tar products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All Coal Tar Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1122-2016·2016-07-13

    Reliable Drug Recalls Compounded Sucralfate Products Due to Processing Controls

    Reliable Drug is recalling all compounded sucralfate products due to a lack of processing controls. The recall covers products distributed in California, Hawaii, and New Mexico.

    Product
    All sucralfate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1159-2016·2016-07-13

    Cantrell Drug Recalls Heparin Sodium Syringes Due to Stability Data Issues

    Cantrell Drug Company is recalling 352 syringes of Heparin Sodium 0.5 USP UNITS/mL because stability data does not support the expiration date.

    Product
    HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2132-2016·2016-07-13

    Lifeline CPR Rescue Kits Recalled for Prescription-Only Mask Component

    Lifeline First Aid LLC is recalling CPR rescue kits because the included CPR shield mask is cleared only for prescription use, not over-the-counter.

    Product
    Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. UPC Red col
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-1908-2016·2016-07-13

    Hummingbird Med Recalls Hummi Micro Draw Blood Transfer Devices

    Hummingbird Med is recalling 62,400 Hummi Micro Draw Blood Transfer Devices distributed in California due to insertion difficulties.

    Product
    ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1082-2016·2016-07-13

    Reliable Drug Recalls PCCA Lipoderm Products Due to Processing Controls

    Reliable Drug is recalling PCCA Lipoderm products compounded in 2015-2016 due to a lack of processing controls.

    Product
    All PCCA Lipoderm Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1089-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Quinine Products Due to Processing Controls

    Reliable Compounding Pharmacy is recalling all quinine products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All quinine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states

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