The Recall Desk

Archive

May 2013 recalls

607 recalls were announced in May 2013.

What the numbers show

Critical
23
Severe
225
High
139
Moderate
183
Low
37

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

Which agencies issued them

501–600 of 607

  • ModerateFDA (Food)·F-1357-2013·2013-05-08

    Spicy Cucumber Fruit Bar Recalled for Undeclared Food Dyes

    Paleteria Y Neveria La Rosita, LLC is recalling Spicy Cucumber Fruit Bars because they contain undeclared FD&C Yellow # 6 and Blue # 1.

    Product
    Spicy Cucumber Fruit Bar , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic ingredients: water, cucumber, sugar, orange juice, lime juice, salt, citric acid, chili powder, yellow 5, red 40 UPC Code 8 94163 00210 6
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1094-2013·2013-05-08

    Trophy CareStream Dental X-ray System Recalled for Bent Connector Defect

    Trophy Sas is recalling CareStream Dental Kodak 2100 Intraoral X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.

    Product
    CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1214-2013·2013-05-08

    NxStage PureFlow-B Solution Recalled for Potential Mislabeled Product

    NxStage Medical is recalling 1,480 cases of PureFlow-B Solution due to potential mislabeling. The product is used for hemodialysis.

    Product
    NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1095-2013·2013-05-08

    Trophy CareStream Dental Kodak 2200 Intraoral X-ray System Recall

    Trophy Sas is recalling CareStream Dental Kodak 2200 Intraoral X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.

    Product
    CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1359-2013·2013-05-08

    Watermelon Fruit Bar Recalled for Undeclared FD&C Blue # 1

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Watermelon Fruit Bars because they contain undeclared FD&C Blue # 1. The product was sold in Michigan and Indiana.

    Product
    Watermelon Fruit Bar , 4 oz. Undeclared FD&C Blue # 1 packaged in clear flexible plastic ingredients: water, watermelon, sugar, red 40 UPC Code 8 94163 00210 6
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1208-2013·2013-05-08

    GE Healthcare Recalls 1.5T SIGNA HDe MR Systems for Image Flip Issue

    GE Healthcare is recalling 822 GE 1.5T SIGNA HDe MR systems worldwide due to a software issue that may cause left-to-right image flips in specific reformatted views.

    Product
    GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-306-2013·2013-05-08

    Donnatal Extentabs Recalled for Incorrect Expiration Date Labeling

    West-ward Pharmaceutical is recalling 1,258 bottles of Donnatal Extentabs because the bottles are labeled with an expiration date of April 2015 instead of the correct April 2013.

    Product
    Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1187-2013·2013-05-08

    Masimo Recalls Rad-8 Pulse Oximeters Due to Unintended Power-Off Defect

    Masimo is recalling 42,908 Rad-8 pulse oximeters worldwide because a small percentage of devices may power off unexpectedly when the patient cable is moved.

    Product
    Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1180-2013·2013-05-08

    Advanced Sterilization Products Recalls STERRAD CYCLESURE 24 Biological Indicators

    Advanced Sterilization Products is recalling STERRAD CYCLESURE 24 Biological Indicators because the company lacks adequate data to support the entire labeled shelf-life.

    Product
    STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1355-2013·2013-05-08

    Vanilla Eskimo Dessert Bar Recalled for Undeclared Food Dye

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz Vanilla Eskimo Dessert Bars because the product contains undeclared FD&C Yellow #6.

    Product
    Vanilla Eskimo Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 in clear flexible package, ingredients: water, chocolate coating (coconut oil, sugar, partially hydrogenated coconut and soybean oil, cocoa, corn starch, soy lecithin, etc.) red 40, yellow 5 UPC Code 8 94163 00230 4
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-304-2013·2013-05-08

    Warner Chilcott Recalls Jevantique Tablets Due to Chemical Contamination

    Warner Chilcott is recalling Jevantique tablets because 2-phenylphenol was found in the product. The contamination resulted from migration from the cardboard cartons used for packaging.

    Product
    Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0999-2013·2013-05-08

    Trophy CareStream Dental CS 2100 X-ray System Recalled for Defective Connector

    Trophy Sas is recalling CareStream Dental CS 2100 X-ray systems due to a bent connector causing poor contact in the high-tension transformer power pin.

    Product
    CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-302-2013·2013-05-08

    Hi-Tech Pharmacal Recalls Subpotent Acetic Acid Otic Solution

    Hi-Tech Pharmacal is recalling 11,472 bottles of Acetic Acid Otic Solution because the product failed potency testing. The recall covers nationwide distribution and Puerto Rico.

    Product
    Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-305-2013·2013-05-08

    Warner Chilcott Recalls Femhrt Tablets Due to Chemical Contamination

    Warner Chilcott is recalling 6,408 bottles of Femhrt tablets because 2-phenylphenol was found in the product. The chemical migrated from the cardboard cartons used for packaging.

    Product
    Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1362-2013·2013-05-08

    Bubble Gum Frozen Dessert Bar Recalled for Undeclared Red Dye

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Bubble Gum Frozen Dessert Bars because the product contains undeclared FD&C Red # 3.

    Product
    Bubble Gum Frozen Dessert Bar , 4 oz. Undeclared FD&C Red # 3 packaged in clear flexible plastic, ingredients: water, sugar, citric acid, blue 1 UPC Code 8 94163 00210 6
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-1363-2013·2013-05-08

    Strawberry Fruit Bar Recalled for Undeclared FD&C Blue # 1 Ingredient

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Strawberry Fruit Bars sold in Michigan and Indiana because the product contains undeclared FD&C Blue # 1.

    Product
    Strawberry Fruit Bar , 4 oz. Undeclared FD&C Blue # 1 ingredients: water, strawberries, sugar, citric acid, red 40 UPC Code 8 94163 00210 6
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-1364-2013·2013-05-08

    Strawberry Eskimo Dessert Bar Recalled for Undeclared FD&C Blue # 1

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Strawberry Eskimo Dessert Bars because the product contains undeclared FD&C Blue # 1.

    Product
    Strawberry Eskimo Dessert Bar , 4 oz. Undeclared FD&C Blue # 1 packaged in clear flexible plastic, ingredients: water, chocolate coating (coconut oil, sugar, partially hydrogenated coconut and soybean oil, cocoa, corn starch, soy lecithin, etc.) red 40, UPC Code 8 94163 00230 4
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-301-2013·2013-05-08

    Percocet 10/325 mg Tablets Recalled Due to Foreign Tablet Presence

    Physicians Total Care is recalling one bottle of Percocet 10/325 mg tablets because it contained a foreign Endocet 10/25 mg tablet.

    Product
    Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg. By: Novartis Consumer Health I, Lincoln, NE 68581; NDC 54868-4710-0, Barcode 47101006IHD.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Food)·F-1361-2013·2013-05-08

    Strawberry Milk Dessert Bar Recalled for Undeclared FD&C Blue # 1

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Strawberry Milk Dessert Bars sold in Michigan and Indiana due to undeclared FD&C Blue # 1.

    Product
    Strawberry Milk Dessert Bar , 4 oz. Undeclared FD&C Blue # 1 ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, red 40, UPC Code 8 94163 00220 5
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-310-2013·2013-05-08

    Reckitt Benckiser Recalls Cherry Cepacol Sore Throat Lozenges for Low Benzocaine

    Reckitt Benckiser is recalling Cherry Cepacol Sore Throat Lozenges because the active ingredient, benzocaine, did not meet stability specifications.

    Product
    Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1360-2013·2013-05-08

    Pina Colada Dessert Bar Recalled for Undeclared Food Dye

    Paleteria Y Neveria La Rosita, LLC is recalling Pina Colada Dessert Bars because the product contains undeclared FD&C Red #40.

    Product
    Pina Colada Dessert Bar , 4 oz. Undeclared FD&C Red # 40 in clear flexible plastic, ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, cream of coconut, whey powder,
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·13V179000·2013-05-07

    Lion Bus Recalls One 2014 Model 360 Bus for Brake Line Chafing

    Lion Bus is recalling one 2014 model year 360 bus because the air compressor and hydraulic brake lines may chafe, causing a hole in the brake line and increasing crash risk.

    Product
    LION — LION 360
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V175000·2013-05-07

    Chrysler Recalls Jeep Grand Cherokee and Commander for Electrical Defect

    Chrysler is recalling 2005-2010 Jeep Grand Cherokee and 2006-2010 Jeep Commander vehicles because an electrical failure may cause the transfer case to shift into neutral, increasing crash risk.

    Product
    JEEP — JEEP GRAND CHEROKEE, COMMANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V181000·2013-05-07

    Heartland Recalls 2013-2014 Trailers Due to Awning Motor Defect

    Heartland is recalling 2013-2014 travel and fifth-wheel trailers because awning motors may be damaged, causing the awning to unfurl unexpectedly and increasing injury or crash risk.

    Product
    HEARTLAND — HEARTLAND SUNDANCE XLT, BIG COUNTRY, LANDMARK, PROWLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V177000·2013-05-07

    Chrysler Recalls 2013 RAM 1500 Trucks for Defective Coolant Valve

    Chrysler is recalling 2013 RAM 1500 trucks because a stuck coolant valve may prevent the windshield defrosting system from working, increasing crash risk.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V174000·2013-05-06

    Dutchmen Recalls 2013 Breckenridge RVs Due to Awning Motor Defect

    Dutchmen is recalling 2013 Breckenridge recreational vehicles because an awning motor defect may cause the awning to unfurl unexpectedly, increasing the risk of injury or a crash.

    Product
    BRECKENRIDGE — BRECKENRIDGE BRECKENRIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·13182·2013-05-02

    LEM 5-Tray Food Dehydrators Recalled Due to Fire Hazard

    LEM Products Distribution is recalling 5-Tray Food Dehydrators because a fan failure can cause the unit to overheat and start a fire. Consumers should stop using the product and contact the company for repair.

    Product
    5-Tray Dehydrator with Digital Timer
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V172000·2013-05-02

    BMW Recalls 2002-2003 Models Due to Passenger Air Bag Defect

    BMW is recalling 2002-2003 models because the passenger air bag inflator may rupture, sending metal fragments into the cabin during a crash.

    Product
    BMW — BMW 325XI, 325IT, M3, 325XIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E023000·2013-05-02

    KONI Recalls Shock Absorbers with Incorrectly Welded Brackets

    KONI North America is recalling specific shock absorbers with incorrectly welded brackets that may bend and rest on the drive shaft, potentially compromising vehicle handling.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13183·2013-05-02

    Louisville Slugger OneX Fastpitch Softball Bats Recalled Due to Breakage Hazard

    Hillerich & Bradsby is recalling approximately 13,000 Louisville Slugger OneX Fastpitch softball bats because the barrel can separate from the handle during use, posing a risk of injury to nearby people.

    Product
    Louisville Slugger® OneX Fastpitch softball bat
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-267-2013·2013-05-01

    Dietary Supplement Recalled for Undeclared Drug Ingredients

    Brower Enterprises Inc. is recalling WOW Health Enterprises Dietary Supplement because it contains undeclared drug ingredients, making it an unapproved drug.

    Product
    WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1002 E 5th St., Canton, SD 57013. Manufactured by Riger Natural, S. A. Mexico.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-283-2013·2013-05-01

    BiMix Standard Injectable Recalled for Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling BiMix Standard Injectable due to lack of sterility assurance and quality control concerns.

    Product
    BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-285-2013·2013-05-01

    FDA Recalls Quadmix Custom Injectable Due to Sterility Assurance Concerns

    Axium Healthcare Pharmacy is recalling Quadmix Custom Injectable vials due to lack of sterility assurance and quality control concerns.

    Product
    Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1347-2013·2013-05-01

    Wild Blue Yonder Recalls Gluten-Free Granola for Undeclared Almonds

    Wild Blue Yonder Foods is recalling Chappaqua Crunch GF Simply Granola with Flax & Fruit due to undeclared almonds. The product was distributed in nine states.

    Product
    Chappaqua Crunch GF(Gluten Free) Simply Granola with Flax & Fruit , 12 ounce pouch UPC: 786516-76002 6
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Drugs)·D-281-2013·2013-05-01

    Axium Healthcare Recalls Mono-mix Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Mono-mix (Prostaglandin) Injectable due to lack of assurance of sterility and quality control concerns.

    Product
    Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1168-2013·2013-05-01

    GE Healthcare Recalls Ventri Discovery NM 530c Nuclear Imaging Systems

    GE Healthcare is recalling 556 Ventri Discovery NM 530c nuclear imaging systems because a moving table mechanism can pinch patient fingers during an exam.

    Product
    Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Drugs)·D-275-2013·2013-05-01

    Axium Healthcare Recalls Cyanocobalamin Injectables Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Cyanocobalamin (CMP) Injectable vials due to a lack of assurance of sterility and quality control concerns.

    Product
    Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-276-2013·2013-05-01

    FDA Recalls Methylcobalamin and Folic Acid Injectables Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Methylcobalamin and Folic Acid Injectables because the products may lack sterility assurance.

    Product
    Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1157-2013·2013-05-01

    Spinal Solutions Recalls APLIF Implants Due to Inadequate Testing

    Spinal Solutions is recalling 220 APLIF implants because they lack adequate testing to prove safety. The defect could cause implant breakage or movement.

    Product
    APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree 184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm - 10degree 184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-286-2013·2013-05-01

    Axium Healthcare Recalls 17 Alpha Hydroxyprogesterone Caproate Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling 17 Alpha Hydroxyprogesterone Caproate Injectable vials due to lack of sterility assurance and quality control concerns.

    Product
    17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-287-2013·2013-05-01

    QuadMix Injectable Recalled for Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling QuadMix Injectable due to lack of sterility assurance and quality control concerns.

    Product
    QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-273-2013·2013-05-01

    Betamethasone Injectable Recalled Due to Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling Betamethasone Injectable due to lack of sterility assurance and quality control concerns.

    Product
    Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-295-2013·2013-05-01

    Axium Healthcare Recalls Cyclosporin Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling all lots of Cyclosporin in Corn Oil Injectable due to lack of assurance of sterility and quality control concerns.

    Product
    Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-284-2013·2013-05-01

    BiMix Plus Injectable Recalled Due to Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling BiMix Plus Injectable due to lack of sterility assurance and quality control concerns.

    Product
    BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-280-2013·2013-05-01

    Axium Healthcare Recalls Comprehensive Injection #4 Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Comprehensive Injection #4 because the compounding process lacked assurance of sterility. The product was distributed in Colorado, Georgia, Michigan, and Puerto Rico.

    Product
    Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1156-2013·2013-05-01

    Orthopedic Alliance Recalls Blue & Gold Spine System Implants

    Orthopedic Alliance LLC is recalling Blue & Gold Spine System implants and instruments because the system lacks adequate testing and documentation to demonstrate it meets performance or safety standards.

    Product
    Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod 5.5 x 40mm BGR0050 Straight Rod 5.5 x 50mm BGR0060 Straight Rod 5.5 x 60mm BGR0070 Straight Rod 5.5 x 70mm BGR0080 Straight Rod 5.5 x 80mm BGR0090 Straight Rod…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-290-2013·2013-05-01

    FDA Recalls Triamcinolone Diacetate Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling 172 vials of Triamcinolone Diacetate Injectable due to lack of sterility assurance and quality control concerns.

    Product
    Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-293-2013·2013-05-01

    Axium Healthcare Recalls Sodium Tetradecyl Sulfate Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Sodium Tetradecyl Sulfate for Injectable due to lack of assurance of sterility and quality control concerns.

    Product
    Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-292-2013·2013-05-01

    HCG Lyophilized Powder Recalled for Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling HCG Lyophilized Powder 10,000 unit for Injectable due to lack of sterility assurance. The product was distributed in Colorado, Georgia, Michigan, and Puerto Rico.

    Product
    HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-277-2013·2013-05-01

    Progesterone Injectable Recalled Due to Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling all lots of Progesterone in Olive Oil Injectable due to lack of sterility assurance and quality control concerns.

    Product
    Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereNHTSA·13V171000·2013-05-01

    Volvo Bus 9700 Recall: Software Defect May Fix Throttle Speed

    Volvo Bus is recalling 2009-2013 9700 coaches because a software defect may fix the throttle at 1750 RPMs, preventing drivers from controlling speed.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-271-2013·2013-05-01

    Methylprednisolone Acetate Injectable Recalled for Sterility Assurance Concerns

    Axium Healthcare Pharmacy is recalling Methylprednisolone Acetate injectable vials due to lack of sterility assurance and quality control concerns.

    Product
    Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-291-2013·2013-05-01

    Axium Healthcare Recalls Triamcinolone Acetonide Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Triamcinolone Acetonide Injectable due to a lack of assurance of sterility and quality control concerns.

    Product
    Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-278-2013·2013-05-01

    FDA Recalls Cyclosporin Ophthalmic Vials Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Cyclosporin (Grapeseed Oil) Ophthalmic vials due to a lack of assurance of sterility and quality control concerns.

    Product
    Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-279-2013·2013-05-01

    Phosphatidylcholine Injectable Recalled for Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling Phosphatidylcholine Injectable due to lack of sterility assurance and quality control concerns.

    Product
    Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-294-2013·2013-05-01

    BiMix Customs Injectable Recalled for Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling BiMix Customs Injectable due to lack of sterility assurance and quality control concerns.

    Product
    BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-289-2013·2013-05-01

    Axium Healthcare Recalls Bacteriostatic Water for Injection Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling all lots of Bacteriostatic Water for Injection 0.9% due to lack of sterility assurance and quality control concerns.

    Product
    Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-270-2013·2013-05-01

    Axium Healthcare Recalls TriMix Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling TriMix Injectable vials due to lack of sterility assurance and quality control concerns.

    Product
    TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-282-2013·2013-05-01

    Trimix Injectable Recalled by Axium Healthcare Pharmacy for Sterility Concerns

    Axium Healthcare Pharmacy is recalling Trimix injectable vials due to a lack of assurance of sterility and quality control concerns.

    Product
    Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-274-2013·2013-05-01

    Axium Healthcare Recalls Triamcinolone Hexacetonide Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Triamcinolone Hexacetonide Injectable vials due to a lack of assurance of sterility and quality control concerns.

    Product
    Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-272-2013·2013-05-01

    Sodium Tetradecyl Sulfate Injectable Recalled for Sterility Assurance Concerns

    Axium Healthcare Pharmacy is recalling Sodium Tetradecyl Sulfate Injectable due to lack of sterility assurance and quality control concerns.

    Product
    Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-288-2013·2013-05-01

    Axium Healthcare Recalls DMSO Bladder Irrigation Solution Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling DMSO 50% Sterile Bladder Irrigation Solution because the company cannot ensure the product is sterile.

    Product
    DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-1167-2013·2013-05-01

    Beckman Coulter AU5800 Clinical Chemistry Analyzer Recalled for Software Error

    Beckman Coulter is recalling 490 AU5800 Clinical Chemistry Analyzers due to a software error that may cause the system to misidentify samples and report erroneous patient results.

    Product
    AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This…
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1154-2013·2013-05-01

    Nova StatStrip Xpress Glu-Test Strips Recalled for No Result Messages

    Nova Biomedical Corporation is recalling specific lots of Nova StatStrip Xpress Glu-Test Strips because they may display a 'no result' message when tested.

    Product
    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2013·2013-05-01

    Ortho-Clinical Diagnostics Recalls VITROS Phenobarbital Slides Due to Accuracy Issues

    Ortho-Clinical Diagnostics is recalling VITROS Phenobarbital Slides because they may produce inaccurate, positively biased patient results that quality controls might miss.

    Product
    VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1321-2013·2013-05-01

    SIB, Inc. Recalls Bakehouse Granola for Undeclared Milk Allergen

    SIB, Inc. is recalling specific lots of Bakehouse Granola because the packaging fails to list milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    Bakehouse Granola, 12 oz, 340 g Scholar's Inn Bakehouse Granola 16 oz, 454 g All Natural, Baked locally
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1164-2013·2013-05-01

    GE Healthcare Recalls Xeleris 2 Workstation Due to Software Artifact Risk

    GE Healthcare is recalling 11 Xeleris 2 Processing & Review Workstations due to a software issue that may cause image artifacts in MPI studies, potentially leading to misdiagnosis.

    Product
    GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT)…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1165-2013·2013-05-01

    Philips NeuViz 16 CT Scanner Recalled Due to Pinch Hazard

    Philips and Neusoft are recalling 23 NeuViz 16 CT scanners because a user error could cause personnel injuries, including a reported finger pinch.

    Product
    NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1352-2013·2013-05-01

    Planet Food Recalls Yum Nature Tahini Due to Salmonella Risk

    Planet Food is recalling Yum Nature Tahini because it has the potential to be contaminated with Salmonella.

    Product
    Yum Nature Tahini, Net Wt. 18oz (1lb.2oz.)510g,12 jars/case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1339-2013·2013-05-01

    All One Active Senior Multiple Vitamin Powder Recalled for Mislabeling

    All One, Inc. is recalling 796 units of Active Senior Multiple Vitamin & Mineral Powder because the label incorrectly claims 'No Dairy' and 'Certified Vegan' despite containing whey protein isolate.

    Product
    all One Active Senior Multiple Vitamin & Mineral Powder dietary supplement, 30 Day Supply, 15.9 oz. canisters
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1166-2013·2013-05-01

    Philips NeuViz Dual CT Scanner Recalled for Pinch Hazard

    Philips and Neusoft are recalling 25 NeuViz Dual CT scanners because user error can cause personnel injuries, including a reported finger pinch.

    Product
    NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V169000·2013-05-01

    Newmar Motorhomes Recalled for Awning Motor Damage Risk

    Newmar is recalling 2013-2014 motorhomes because an awning motor may be damaged during installation, causing the awning to unfurl unexpectedly and increasing injury or crash risk.

    Product
    NEWMAR — NEWMAR CANYON STAR, DUTCH STAR, VENTANA, VENTANA LE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1340-2013·2013-05-01

    All One Multiple Vitamin Powder Recalled for Misleading Dairy Labeling

    All One, Inc. is recalling multiple vitamin powder canisters because the label incorrectly claims 'No Dairy' and 'Certified Vegan' despite containing milk.

    Product
    all One Original Formula Multiple Vitamin & Mineral Powder dietary supplement, 30 Day Supply, 15.9 oz. canisters
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2013·2013-05-01

    Accuray RoboCouch Patient Positioning System Recalled for Defective Gearboxes

    Accuray Incorporated is recalling 16 RoboCouch Patient Positioning Systems because A5 gearboxes responsible for pitch and roll motions may be defective.

    Product
    RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1153-2013·2013-05-01

    Nova StatStrip Xpress Glu-Test Strips Recalled for No Result Messages

    Nova Biomedical is recalling specific lots of Nova StatStrip Xpress Glu-Test Strips because they may display a 'no result' message when tested.

    Product
    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1080-2013·2013-05-01

    Stellate Systems Recalls Harmonie Software Due to FDA Clearance Issues

    Stellate Systems is recalling Harmonie software versions 5.1 to 6.2e because the product's labeling indications have not been cleared by the FDA for sale in the USA.

    Product
    Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1163-2013·2013-05-01

    Varian RPM Respiratory Gating System Recall for Waveform Anomaly

    Varian is recalling RPM Respiratory Gating System v1.7.5 units because they may produce inverted respiratory waveforms during specific sessions.

    Product
    Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-298-2013·2013-05-01

    Qualitest Recalls Glimepiride Tablets Due to Oversized Tablet Finding

    Qualitest Pharmaceuticals is recalling 10,373 bottles of Glimepiride 2 mg tablets because one oversized tablet was found in a sealed bottle at the retail level.

    Product
    GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-299-2013·2013-05-01

    Pentrexcilina Tablets Recalled for Misleading Labeling Confusion

    OPMX, LLC is recalling Pentrexcilina tablets because the labels are misleading and may be confused with a prescription antibiotic.

    Product
    Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton, Distributed by: Laboratorios Norimex Co., San Diego, CA 92154, UPC 0 91965 02002 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1173-2013·2013-05-01

    DePuy Mitek Recalls Blue Orthocord Sutures Due to Inaccurate Strength Labeling

    DePuy Mitek is recalling Blue Orthocord sutures because the instructions for use incorrectly state they retain 100% strength at six weeks, when they actually retain approximately 80%.

    Product
    ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-300-2013·2013-05-01

    Pentrexcilina Liquid Recalled for Misleading Labeling Confusion with Prescription Antibiotic

    OPMX, LLC is recalling Pentrexcilina Jarabe NF liquid because its label may be confused with Pentrexyl, a prescription antibiotic.

    Product
    Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle, Distributed by Laboratorios Nordimex Co., San Diego, CA 92154, UPC 0 91965 02001 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1346-2013·2013-05-01

    Jasmine Garlic Crackers Recalled for Undeclared Food Dyes

    Wira Corp. is recalling Jasmine Garlic Flavored Crackers due to undeclared and unapproved food color ingredients.

    Product
    Jasmine Brand Garlic Flavored Crackers (Krupuk Bawang), 40x250gr.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1344-2013·2013-05-01

    Ozone Confectioners Recalls Non-Pareil Seeds Due to Undeclared Dyes

    Ozone Confection & Bakers Supply Co. is recalling 481 units of Non-Pareil Seeds because they contain undeclared FD&C colors.

    Product
    Harvest Mix Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1178-2013·2013-05-01

    Alere Cholestech LDX hsCRP Test Cassette Recall for Imprecision

    Alere San Diego, Inc. is recalling 2,333 Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassettes due to increased imprecision that may affect quantitative results.

    Product
    The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1343-2013·2013-05-01

    Ozone Confectioners Recalls Non-Pareil Seeds Due to Undeclared Dyes

    Ozone Confection & Bakers Supply Co. is recalling 481 boxes of Non-Pareil Seeds because they contain undeclared FD&C colors.

    Product
    Assorted Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-1345-2013·2013-05-01

    Ozone Confectioners Recalls Easter Mix Non-Pareil Seeds for Undeclared Dyes

    Ozone Confection & Bakers Supply Co. is recalling 481 units of Easter Mix Non-Pareil Seeds because they contain undeclared FD&C colors.

    Product
    Easter Mix Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1174-2013·2013-05-01

    DePuy Mitek Recalls ORTHOCORD Sutures Due to Inaccurate Strength Labeling

    DePuy Mitek is recalling ORTHOCORD sutures because the instructions for use incorrectly state that Blue sutures retain 100% strength at six weeks.

    Product
    ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1158-2013·2013-05-01

    Teleflex Medical Recalls Belly Bag Urine Collection Bags Due to Packaging Concerns

    Teleflex Medical is recalling 190,103 sterile Belly Bag Urine Collection Bags with Hip Belts because the sterile packaging may be compromised.

    Product
    Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-297-2013·2013-05-01

    Hospira Recalls Propofol Injectable Vials Due to Particulate Matter

    Hospira Inc. is recalling 245,250 vials of Propofol Injectable Emulsion because a single visible particulate was found during a retain sample inspection.

    Product
    PROPOFOL — PROPOFOL (PROPOFOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1172-2013·2013-05-01

    DePuy Mitek Recalls Blue Orthocord Sutures Due to Inaccurate Labeling

    DePuy Mitek is recalling Blue Orthocord sutures because the instructions for use incorrectly state that 100% suture strength remains at six weeks.

    Product
    ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1351-2013·2013-05-01

    Royal Foods Recalls Pantai Thai Tea Due to Insanitary Conditions

    Royal Foods, Inc. is recalling Pantai Thai Tea because a state audit found insanitary conditions, including a leaking roof and rodent activity, at the facility.

    Product
    Pantai Thai Tea The tea is packaged in a foil laminated pouch Product of Thailand
    Category
    Food
    Distribution
    1 state

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