The Recall Desk

Archive

November 2014 recalls

908 recalls were announced in November 2014.

What the numbers show

Critical
20
Severe
221
High
214
Moderate
428
Low
25

Of the 908 recalls this month scored against our rubric, 2% are Critical, 24% are Severe.

Which agencies issued them

401–500 of 908

  • SevereFDA (Devices)·Z-0142-2015·2014-11-05

    Mabis Recalls DMI Rollator Transport Chairs Due to Collapse Risk

    Briggs Medical Service Company is recalling 1,869 DMI Rollator Transport Chairs because they may collapse during use.

    Product
    DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; Walking assistance device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0076-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Dexamethasone Sodium Phosphate Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Dexamethasone sodium phosphate 4 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Dexamethasone sodium phosphate 4 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0096-2015·2014-11-05

    Real Foods Recalls Mexican Cheddar Dip for Missing Egg Labeling

    Real Foods of Seattle is recalling 96 units of Mexican Cheddar Dip because egg is missing from the ingredient statement.

    Product
    Mexican Cheddar Dip 10oz non-flex plastic, distributed by Taylor Farms Salinas, CA 93902. The label will show UPC 0 3022300960 9 or UPC 0 30223 00952 8
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0112-2015·2014-11-05

    FDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue

    The FDA is recalling 324 Puritan Bennett 980 ventilators because a software issue may cause the devices to become inoperative.

    Product
    Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Drugs)·D-0123-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Polyhexamethylene biguanide 2% stock solution, due to quality control issues affecting sterility assurance.

    Product
    Polyhexamethylene biguanide 2% stock solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0072-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including cyanocobalamin, due to quality control observations that risk sterility assurance.

    Product
    Cyanocobalamin 1000 mcg/mL injectable solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0117-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Phenol 10% Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Phenol 10% injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Phenol 10% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0066-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Cefazolin Ophthalmic Solution for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Cefazolin ophthalmic solution due to quality control issues that may compromise sterility.

    Product
    Cefazolin forte 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0080-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Fentanyl Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling fentanyl injectable syringes due to quality control issues that may compromise sterility assurance.

    Product
    Fentanyl injectable 2000 mcg/mL packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0054-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Acetylcysteine Inhalant Solution Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Acetylcysteine 10% inhalant solution due to quality control observations that present a risk to sterility assurance.

    Product
    Acetylcysteine 10% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0151-2015·2014-11-05

    Joerns EasyCare Bed Recalled Due to Care-Lock Feature Failure Risk

    Joerns Healthcare is recalling 3,135 EasyCare Beds because the Care-Lock feature may fail to stay engaged, posing a safety risk to patients.

    Product
    Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed is a device intended for medical purposes. The bed includes a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0064-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Bupivacaine Hydrochloride Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Bupivacaine hydrochloride 0.25% injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Bupivacaine hydrochloride 0.25% injectable packaged in an amber glass injectable vial,Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0162-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix T102 injectable vials because quality control issues identified during an FDA inspection may compromise sterility.

    Product
    Tri-mix T102, 17.65 mg/0.59 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0136-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Sodium Tetradecyl Sulfate Injectable

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations due to quality control observations that present a risk to sterility assurance.

    Product
    Sodium tetradecyl sulfate 5% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0151-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.

    Product
    Tri-mix, 30 mg/2 mg/20 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0117-2015·2014-11-05

    Good Herbs Bee Formula Recalled for GMP Violations

    Good Herbs, Inc. is recalling Bee Formula bottles because they were not manufactured under Good Manufacturing Practices (GMPs).

    Product
    Good Herbs, Inc., BEE FORMULA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works
    Category
    Food
    Distribution
    18 states
  • HighFDA (Drugs)·D-0105-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including morphine/bupivacaine, due to quality control issues affecting sterility assurance.

    Product
    Morphine/bupivacaine 5 mg/2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0082-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Glycerin Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Glycerin 72% sodium chloride injectable vials due to quality control observations that risk sterility assurance.

    Product
    Glycerin 72% (w/v) sodium chloride injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0130-2015·2014-11-05

    Siemens Recalls ADVIA Centaur Ferritin Calibrator C Due to Realignment Issue

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator C kits due to a realignment issue with Ferritin Analytical Sensitivity. The recall affects 234 kits distributed worldwide.

    Product
    ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0143-2015·2014-11-05

    Merge Hemo Diagnostic Computer Recalled for Stale Oxygen and Heart Rate Data

    Merge Healthcare is recalling 52 Hemo Programmable diagnostic computers because the SpO2 and heart rate values displayed may not update to reflect changes in the patient's condition.

    Product
    Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0144-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including triamcinolone acetonide, due to quality control observations that risk sterility assurance.

    Product
    Triamcinolone acetonide suspending vehicle (PF) vehicle packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0084-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.

    Product
    Histamine 2.75 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0097-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Lidocaine 2% Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Lidocaine 2% injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.

    Product
    Lidocaine 2% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0115-2015·2014-11-05

    Martin Avenue Pharmacy Recalls PGE 4 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling PGE 4 injectable vials because quality control issues identified during an FDA inspection present a risk to sterility assurance.

    Product
    PGE 4, 300 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0147-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix, 15 mg/0.5 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0156-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix ST2 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST2 injectable vials because quality control issues identified during an FDA inspection may compromise sterility.

    Product
    Tri-mix ST2, 30 mg/3 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0146-2015·2014-11-05

    Roche Recalls ACCU-CHEK Spirit Combo Insulin Pumps Due to Time Settings

    Roche is recalling 8,116 ACCU-CHEK Spirit Combo insulin pumps because a faulty capacitor may cause time and date settings to reset, potentially shifting insulin delivery schedules.

    Product
    ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0171-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Fentanyl/Bupivacaine Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling fentanyl/bupivacaine injectable syringes due to quality control observations that present a risk to sterility assurance.

    Product
    Fentanyl/bupivacaine 3000 mcg/30 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0126-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Quad Mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Quad Mix injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Quad mix, 18 mg/0.2 mg/10 mcg/0.02 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2015·2014-11-05

    Siemens Phenytoin Reagent Cartridge Recalled for Potential Test Bias

    Siemens Healthcare Diagnostics is recalling 1,733 Phenytoin Flex Reagent Cartridges due to internal testing that confirmed a low absorbance range, which may result in biased or imprecise test results.

    Product
    siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0092-2015·2014-11-05

    United Natural Trading Recalls Organic Campfire Trail Mix for Undeclared Cashews

    United Natural Trading is recalling three brands of Organic Campfire Trail Mix because they may contain undeclared cashew kernels.

    Product
    1) Nature's Place Organic Campfire Trail Mix; Net. Wt. 12 oz. (340 g); Distributed by DZA Brands LLC 2110 Executive Drive Salisbury, NC 28147; UPC 725439951920 2) Nature's Promise Organic Campfire Trail Mix; Net. Wt. 12 oz. (340 g); Distributed by Foodhold USA LLC Landover…
    Category
    Food
    Distribution
    7 states
  • HighFDA (Drugs)·D-0065-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including calcium chloride, due to quality control observations that risk sterility assurance.

    Product
    Calcium chloride (PF) 100 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0149-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because quality control issues may compromise sterility assurance.

    Product
    Tri-mix, 30 mg/1 mg/20 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0098-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin 1 mg/mL injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.

    Product
    Methylcobalamin 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0139-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Testosterone cypionate 150 mg/mL injections due to quality control issues that may compromise sterility assurance.

    Product
    Testosterone cypionate 150 mg/mL injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0132-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Sodium Tetradecyl Sulfate Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations of Sodium tetradecyl sulfate due to quality control issues affecting sterility assurance.

    Product
    Sodium tetradecyl SO4 stock solution 6% solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0118-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including phentolamine mesylate, due to quality control issues affecting sterility assurance.

    Product
    Phentolamine mesylate 5 mg/35 mg/mannitol trituration packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2015·2014-11-05

    CP Medical Recalls Monoswift PGCL Sutures for Tensile Strength Failure

    CP Medical is recalling five lots of Monoswift PGCL absorbable surgical sutures because they failed to meet minimum tensile strength requirements over their shelf life.

    Product
    Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0020-2015·2014-11-05

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications S.A. is recalling eight Proteus 235 Proton Therapy Systems due to a rare risk of exceeding prescribed radiation doses.

    Product
    Proteus 235 Proton Therapy System for cancer treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0070-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including chorionic gonadotropin/mannitol, due to quality control issues affecting sterility assurance.

    Product
    Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0415-2015·2014-11-05

    Good Herbs Skullcap Recalled for GMP Violations

    Good Herbs, Inc. is recalling Skullcap herb bottles because they were not manufactured under Good Manufacturing Practices (GMPs).

    Product
    Good Herbs, Inc., SKULLCAP, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works
    Category
    Food
    Distribution
    18 states
  • HighNHTSA·14V709000·2014-11-05

    Ford Recalls 2014 F-150 Trucks Due to Brake Light Switch Defect

    Ford is recalling certain 2014 F-150 vehicles because an improperly adjusted brake pedal position switch may cause brake lights to illuminate with a delay or not at all.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0086-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Hyaluronidase Injection Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling hyaluronidase injection solution due to quality control issues that may compromise sterility.

    Product
    Hyaluronidase injection solution (PF) 150 U/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0099-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin (PF) 1 mg/mL injectable vials due to quality control issues that may compromise sterility assurance.

    Product
    Methylcobalamin (PF) 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0167-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix T50 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix T50 injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix T50, 8.825 mg/0.29 mg/2.95 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0155-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix ST1 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST1 injectable vials because FDA inspection findings raised concerns about sterility assurance.

    Product
    Tri-mix ST1, 30 mg/1.5 mg/50 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0141-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tetracycline Powder Kits for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tetracycline 250 mg powder kits due to quality control observations that present a risk to sterility assurance.

    Product
    Tetracycline 250 mg powder kits packaged with powder and water in separate amber glass vials, with filter, in bag, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0127-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Quad mix 2, due to quality control observations that present a risk to sterility assurance.

    Product
    Quad mix 2, 12 mg/1 mg/25 mcg/0.25 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0090-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Hydromorphone HCl Injectable Syringes

    Martin Avenue Pharmacy is voluntarily recalling compounded Hydromorphone HCl injectable syringes due to quality control observations that present a risk to sterility assurance.

    Product
    Hydromorphone HCl (PF) 1 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0158-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix ST9-A Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST9-A injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix ST9-A, 30 mg/2 mg/80 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0128-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Quad mix, due to quality control observations that present a risk to sterility assurance.

    Product
    Quad mix, 30 mg/1 mg/10 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0079-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Dihydroergotamine Mesylate Injection Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling dihydroergotamine mesylate injections due to quality control issues that may compromise sterility assurance.

    Product
    Dihydroergotamine mesylate 1 mg/mL injection solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0168-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Vancomycin Eye Drops Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Vancomycin 25 mg/mL ophthalmic solution because quality control issues may compromise sterility.

    Product
    Vancomycin 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0133-2015·2014-11-05

    SAM Medical Products Recalls Junctional Tourniquet Auxiliary Straps

    Sam Medical Products is recalling SJT 102 and 112 auxiliary straps because the snap hook broke during a training demonstration.

    Product
    SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0153-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Tri-mix 8.3 low dose, due to quality control issues affecting sterility assurance.

    Product
    Tri-mix 8.3 low dose, 22 mg/0.83 mg/8.3 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0150-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix, 30 mg/2 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2015·2014-11-05

    Maquet Cardiovascular Recalls Cardiac Surgery Systems Due to Tyvek Pouch Defects

    Maquet Cardiovascular is recalling specific cardiac surgery systems because internal findings identified pinholes or cuts in Tyvek pouches within the vacuum tubing sets.

    Product
    Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0100-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin 10 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Methylcobalamin 10 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0152-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because FDA inspection findings raised concerns about sterility assurance.

    Product
    Tri-mix, 30 mg/3 mg/5 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0097-2015·2014-11-05

    Heather's Choice Recalls Salmon Chowder for Undeclared Coconut and Permit Issues

    Heather's Choice is recalling Salmon Chowder because the firm operated without a permit and lacked a HACCP plan. The product also contains undeclared coconut.

    Product
    Salmon Chowder, sold under brand Heather's Choice. The product is labeled in parts: "***Salmon Chowder***HEATHER'S CHOICE***meals for adventuring***ingredients: salmon + peas + carrots + potatoes+ coconut milk powder***directions: cover food with hot water + let sit for 15…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0069-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.

    Product
    Chorionic gonadotropin buffered diluent solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0087-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Assurance Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including hydrochloric acid/water for injection, due to quality control observations that present a risk to sterility assurance.

    Product
    Hydrochloric acid/water for injection 10% (w/v) packaged in an amber glass dropper bottle, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0102-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin (PF) 25 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Methylcobalamin (PF) 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0073-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.

    Product
    Cyclosporine 200 mg/mL opthalmic suspension packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2015·2014-11-05

    Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide

    Actavis Inc is voluntarily recalling 26,663 cartons of Vancomycin Hydrochloride Capsules because the drug was found to be subpotent.

    Product
    Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0164-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix T106 injectable vials because FDA inspection observations raised concerns about sterility assurance.

    Product
    Tri-mix T106, 30 mg/1 mg/25 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0088-2015·2014-11-05

    Ikea Recalls Elk-Shaped Wholemeal Pasta Due to Undeclared Soy

    Ikea North America is recalling 22,025 units of elk-shaped wholemeal pasta because the product contains undeclared soy.

    Product
    Elk shaped pasta Ekologiska PASTA-ALGAR FULLKORN Pasta elks wholemeal, organic NET WT 17.6 OZ (500 g) IKEA PRODUCED IN GERMANY FOR: IKEA FOOD SERVICES
    Category
    Food
    Distribution
    21 states
  • HighFDA (Drugs)·D-0159-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Tri-mix ST9-B, due to quality control issues affecting sterility assurance.

    Product
    Tri-mix ST9-B, 30 mg/2 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0124-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Prednisolone Acetate Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Prednisolone acetate 50 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Prednisolone acetate 50 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0060-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Atropine Sulfate Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 1 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Atropine sulfate 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0094-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Hydroxyzine Hydrochloride Injectable Vials

    Martin Avenue Pharmacy is voluntarily recalling Hydroxyzine hydrochloride 25 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Hydroxyzine hydrochloride 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0114-2015·2014-11-05

    Martin Avenue Pharmacy Recalls PGE 3 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling PGE 3 injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    PGE 3, 200 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0135-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.

    Product
    Sodium tetradecyl sulfate 3% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL..
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0143-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Triamcinolone Acetonide Injection Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded Triamcinolone acetonide injections due to quality control observations that risk sterility assurance.

    Product
    Triamcinolone acetonide (PF) 40 mg/mL injection suspension packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0078-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Diazepam Preparations

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Diazepam, due to quality control issues affecting sterility assurance.

    Product
    Diazepam 5 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0133-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Sodium Tetradecyl Sulfate Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling sodium tetradecyl sulfate 1% injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Sodium tetradecyl sulfate 1% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0170-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Voriconazole Eye Drops for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Voriconazole 10 mg/mL ophthalmic solution due to quality control issues that may compromise sterility.

    Product
    Voriconazole 10 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0074-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations due to quality control observations that present a risk to sterility assurance.

    Product
    Cyclosporine suspending vehicle packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0148-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.

    Product
    Tri-mix, 30 mg/0.5 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0092-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Hydroxocobalamin Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Hydroxocobalamin 5 mg/mL injectable vials due to quality control issues that may affect sterility assurance.

    Product
    Hydroxocobalamin 5 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0104-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Morphine Sulfate Syringes for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded morphine sulfate syringes due to quality control observations that present a risk to sterility assurance.

    Product
    Morphine sulfate (PF) 3 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2015·2014-11-05

    Coloplast Conveen Urine Collection Leg Bag Recalled for Seam Leakage

    Coloplast is recalling Conveen Urine Collection Leg Bags due to potential leakage from the bag seam when filled.

    Product
    Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0101-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin 25 mg/mL injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.

    Product
    Methylcobalamin 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0093-2015·2014-11-05

    Williams Sonoma Pumpkin Seed Pesto Recalled for Botulism Risk

    California Olive and Vine is recalling Williams Sonoma Pumpkin Seed Pesto because improper processing may allow Clostridium botulinum contamination.

    Product
    Williams Sonoma Pumpkin Seed Pesto 8 oz. glass jar
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0113-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations due to quality control observations that present a risk to sterility assurance.

    Product
    PGE 2.5, 150 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0134-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Assurance Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including sodium tetradecyl sulfate, due to quality control issues affecting sterility assurance.

    Product
    Sodium tetradecyl sulfate 2% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2015·2014-11-05

    Medartis Recalls APTUS Ulna Shortening 2.5 Plates Due to Breakage

    Medartis, Inc. is recalling 44 APTUS Ulna Shortening 2.5 plates due to three complaints of temporary tension bolt breakage.

    Product
    APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0169-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Vancomycin Eye Drops Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Vancomycin 50 mg/mL ophthalmic solution due to quality control observations that risk sterility assurance.

    Product
    Vancomycin 50 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0085-2015·2014-11-05

    Pillsbury Biscuits Recalled for Undeclared Milk Ingredient

    General Mills is recalling specific cases of Pillsbury Biscuits Buttermilk 4pk due to incorrect overwrap labeling that fails to declare milk.

    Product
    Cases of refrigerated Pillsbury Biscuits Buttermilk 4pk. (6 - 4pk / case)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-0096-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Lidocaine Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Lidocaine (PF) 1% injectable vials due to quality control issues that may compromise sterility assurance.

    Product
    Lidocaine (PF) 1% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0129-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Quad mix, due to quality control issues that may compromise sterility assurance.

    Product
    Quad mix, 30 mg/1 mg/20 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0086-2015·2014-11-05

    Pillsbury Biscuit Flaky Layers Recalled for Undeclared Milk Ingredient

    General Mills is recalling Pillsbury Biscuit Flaky Layers 4-packs because the outer packaging incorrectly lists the product, creating a risk of undeclared milk for consumers.

    Product
    Pillsbury refrigerated Biscuit Flaky Layers retail 4pk package.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-0163-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix T105 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix T105 injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix T105, 30 mg/1 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0141-2015·2014-11-05

    Trumpf TITAN Operating Room Table Recalled for Unintended Movement

    Trumpf Medical Systems is recalling 184 TITAN Operating Room Tables due to unintended movement during surgery caused by damaged remotes.

    Product
    TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0061-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Atropine Sulfate Injectable Vials

    Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 2 mg/mL injectable vials due to quality control issues that risk sterility assurance.

    Product
    Atropine sulfate 2 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0131-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including triamcinolone injection solutions, due to quality control issues affecting sterility assurance.

    Product
    Rescue solution with triamcinolone (lidocaine, bupivacaine, heparin, triamcinolone) injection solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide

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