The Recall Desk

Archive

April 2015 recalls

1,319 recalls were announced in April 2015.

What the numbers show

Critical
109
Severe
569
High
350
Moderate
275
Low
16

Of the 1,319 recalls this month scored against our rubric, 8% are Critical, 43% are Severe.

Which agencies issued them

401–500 of 1319

  • SevereFDA (Drugs)·D-708-2015·2015-04-29

    Attix Pharmaceuticals Recalls Hyaluronic Acid Sodium Salt Injection Grade API

    Attix Pharmaceuticals is recalling Hyaluronic Acid Sodium Salt (Injection Grade) active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Hyaluronic Acid Sodium Salt (Injection Grade) active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-927-2015·2015-04-29

    Attix Pharmaceuticals Recalls Thiotepa Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Thiotepa active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Thiotepa active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2015·2015-04-29

    Churchill Medical Systems Recalls 8 Inch Standard Bore Extension Sets

    Churchill Medical Systems is recalling 8-inch Standard Bore Extension Sets due to a potential leak caused by insufficient bonding between the needleless device and the female luer.

    Product
    8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1474-2015·2015-04-29

    Churchill Medical Systems Recalls 7-Inch High Pressure Extension Sets

    Churchill Medical Systems is recalling 6,850 units of 7-inch Standard Bore High Pressure Extension Sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.

    Product
    7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-876-2015·2015-04-29

    Attix Pharmaceuticals Recalls Rebamipide Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of Rebamipide API distributed between January 2012 and February 2015 due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Rebamipide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-869-2015·2015-04-29

    Progesterone API Recalled for Potential Penicillin Cross-Contamination

    Attix Pharmaceuticals is recalling progesterone active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Progesterone Ultra-Micronized active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-833-2015·2015-04-29

    Attix Pharmaceuticals Recalls Paroxetine Active Ingredient Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling paroxetine active pharmaceutical ingredient repackaged between January 2012 and February 2015 due to potential penicillin cross-contamination.

    Product
    Paroxetine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-545-2015·2015-04-29

    Attix Pharmaceuticals Recalls Bismuth Subcarbonate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Bismuth Subcarbonate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Bismuth Subcarbonate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2015·2015-04-29

    Churchill Medical 4-inch Microbore T-Port Set Recalled for Leaking Risk

    Churchill Medical Systems is recalling 450 units of 4-inch Microbore T-Port Sets due to a potential leak caused by insufficient bonding between components.

    Product
    4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1495-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects

    Wright Medical Technology is recalling 308 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-579-2015·2015-04-29

    Attix Pharmaceuticals Recalls Chloroquine Phosphate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Chloroquine Phosphate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Chloroquine Phosphate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-522-2015·2015-04-29

    Attix Pharmaceuticals Recalls Anastrozole API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Anastrozole active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Anastrozole active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-852-2015·2015-04-29

    Attix Pharmaceuticals Recalls Povidone K-30 Ingredient Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Povidone K-30 pharmaceutical ingredient lots distributed between January 2012 and February 2015 due to potential penicillin cross-contamination.

    Product
    Povidone K-30 pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1496-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 372 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2010-2015·2015-04-29

    Giant Eagle Recalls GetGo Salads for Undeclared Wheat

    Giant Eagle is recalling GetGo California Chicken Cobb and Grilled Chicken Salads due to undeclared wheat.

    Product
    GETGO California Chix Cobb Salad Sell By: (up to and including) 3/26/15 Net Wt: 14 oz. Contains: Soy, Egg, Milk GetGo Giant Eagle Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1480-2015·2015-04-29

    Captiva Lumbar Fusion Reamers Recalled for Detaching Color Rings

    Captiva Spine is recalling 233 lumbar intervertebral fusion system reamers because the titanium color-coded rings may detach.

    Product
    Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1475-2015·2015-04-29

    Churchill Medical Systems Recalls 7-inch High Pressure Extension Sets

    Churchill Medical Systems is recalling 6,850 units of 7-inch Standard Bore High Pressure Extension Sets due to a potential leak caused by insufficient bonding.

    Product
    7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-767-2015·2015-04-29

    Attix Pharmaceuticals Recalls Lodenafil Carbonate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Lodenafil Carbonate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Lodenafil Carbonate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-881-2015·2015-04-29

    Attix Pharmaceuticals Recalls Ritonavir API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Ritonavir active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Ritonavir active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-871-2015·2015-04-29

    Attix Pharmaceuticals Recalls Pyrazinamide Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Pyrazinamide active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Pyrazinamide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-679-2015·2015-04-29

    Flumazenil API Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Flumazenil active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Flumazenil active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-613-2015·2015-04-29

    Attix Pharmaceuticals Recalls Dapiprazole HCl Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Dapiprazole HCl active pharmaceutical ingredient due to potential penicillin cross-contamination from repackaging in a shared facility.

    Product
    Dapiprazole HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2029-2015·2015-04-29

    Dairy Farmers of America Recalls Borden Good 2 Gether Snack Trays

    Dairy Farmers of America is recalling Borden Good 2 Gether snack trays due to a potential hard plastic fragment hazard.

    Product
    Borden Good 2 Gether, Colby Jack Cheese & Pretzels, UPC: 5300001113, Net Wt 2 0z (57 g), Dist. By DFA Dairy Farmers of America, PO Box 909700, Kansas City, MO 64190.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1951-2015·2015-04-29

    Giant Eagle Recalls GetGo Strawberry Yogurt Parfait for Undeclared Soy

    Giant Eagle is recalling GetGo Strawberry Yogurt Parfait because the label failed to declare soy, a major allergen, present in the granola ingredient.

    Product
    GetGo Giant Eagle Strawberry Yogurt Parfait Sell By: (up to and including) 3/24/2015 Distributed by: Giant Eagle, Inc., Pittsburgh, PA 15238 Contains: Milk, Wheat, Almonds Net Wt: 10 oz.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-816-2015·2015-04-29

    Attix Pharmaceuticals Recalls Nevirapine API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Nevirapine active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Nevirapine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-809-2015·2015-04-29

    Attix Pharmaceuticals Recalls Mupirocin API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Mupirocin active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Mupirocin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-958-2015·2015-04-29

    Attix Pharmaceuticals Recalls Zoledronic Acid Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Zoledronic Acid active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Zoledronic Acid active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-848-2015·2015-04-29

    Attix Pharmaceuticals Recalls Polidocanol Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Polidocanol (Industrial Grade) active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Polidocanol (Industrial Grade) active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-835-2015·2015-04-29

    Attix Pharmaceuticals Recalls Penciclovir Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling penciclovir active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Penciclovir active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-784-2015·2015-04-29

    Attix Pharmaceuticals Recalls Methocarbamol Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling methocarbamol active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Methocarbamol active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-782-2015·2015-04-29

    Attix Pharmaceuticals Recalls Methimazole Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling methimazole active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging. The product was distributed nationwide to compounding pharmacies and research organizations.

    Product
    Methimazole active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-558-2015·2015-04-29

    Attix Pharmaceuticals Recalls Cantharidin Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of cantharidin active pharmaceutical ingredient distributed between January 5, 2012, and February 12, 2015, due to potential penicillin cross-contamination.

    Product
    Cantharidin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-741-2015·2015-04-29

    Attix Pharmaceuticals Recalls Ketoconazole API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of Ketoconazole active pharmaceutical ingredient distributed between January 2012 and February 2015 due to potential penicillin cross-contamination.

    Product
    Ketoconazole active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-673-2015·2015-04-29

    Attix Pharmaceuticals Recalls Felbamate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Felbamate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Felbamate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-524-2015·2015-04-29

    Attix Pharmaceuticals Recalls Artemether Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of Artemether active pharmaceutical ingredient distributed between January 2012 and February 2015 due to potential penicillin cross-contamination.

    Product
    Artemether active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1485-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 102 units of the Crosscheck Plating System because specific dimensions are out of specification, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-751-2015·2015-04-29

    Attix Pharmaceuticals Recalls Letrazole Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Letrazole active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Letrazole active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1490-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 167 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-863-2015·2015-04-29

    Attix Pharmaceuticals Recalls Procainamide HCl Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Procainamide HCl active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Procainamide HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-503-2015·2015-04-29

    Adenosine API Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Adenosine active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Adenosine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2015·2015-04-29

    Hospira PCA 3 Infusion Pump Recalled for Door Design Flaw

    Hospira is recalling 8,214 PCA 3 infusion pumps because the clear plastic door design allows excessive flexing, permitting unauthorized access to medication vials.

    Product
    The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Drugs)·D-732-2015·2015-04-29

    Attix Pharmaceuticals Recalls Indocyanine Green Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Indocyanine Green active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Indocyanine Green active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1497-2015·2015-04-29

    Wright Medical Crosscheck Plating System Recalled for Dimensional Defects

    Wright Medical Technology is recalling 138 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-935-2015·2015-04-29

    Tolvaptan API Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Tolvaptan active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Tolvaptan active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2015·2015-04-29

    DiaSorin Recalls PRO-Trac II Tacrolimus ELISA Kits Due to Instability

    DiaSorin is recalling 451 PRO-Trac II Tacrolimus ELISA kits because instability may cause falsely elevated patient results.

    Product
    DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-839-2015·2015-04-29

    Attix Pharmaceuticals Recalls Phenolphthalein Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Phenolphthalein active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Phenolphthalein active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2015-2015·2015-04-29

    Ricos Tostaditos Vegetal Skins Recalled for Undeclared Wheat and Soy Oil

    Ricos Tostaditos, Inc. is recalling 300 bags of Ricos Tostaditos Vegetal Skins due to undeclared wheat and soy oil allergens.

    Product
    RICOS Tostaditos Vegetal Skins Imitation Rinds Chicharron Vegetal Crispy and Delicious Net Wt. 3/4 oz. (21g)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-786-2015·2015-04-29

    Attix Pharmaceuticals Recalls Methotrexate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Methotrexate USP active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Methotrexate USP active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-860-2015·2015-04-29

    Attix Pharmaceuticals Recalls Pregelatinized Starch Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Pregelatinized Starch pharmaceutical ingredients due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Pregelatinized Starch pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-650-2015·2015-04-29

    Attix Pharmaceuticals Recalls Epinephrine Ingredient Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling epinephrine active pharmaceutical ingredient distributed to compounding pharmacies and research organizations due to potential penicillin cross-contamination.

    Product
    Epinephrine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1488-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects

    Wright Medical Technology is recalling 148 units of the Crosscheck Plating system because specific dimensions are out of specification, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-570-2015·2015-04-29

    Attix Pharmaceuticals Recalls Celecoxib API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling all lots of Celecoxib active pharmaceutical ingredient repackaged between January 2012 and February 2015 due to potential penicillin cross-contamination.

    Product
    Celecoxib active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-660-2015·2015-04-29

    Attix Pharmaceuticals Recalls Ethambutol HCl Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Ethambutol HCl active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Ethambutol HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2015·2015-04-29

    Abbott OptiMedica Catalys Precision Laser System Recalled for Corneal Scoring Risk

    Abbott Medical Optics is recalling 202 OptiMedica Catalys Precision Laser Systems because loss of suction during cataract surgery may cause corneal scoring.

    Product
    OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2015·2015-04-29

    Churchill Medical Systems Recalls 4-inch Microbore Trifurcated Extension Sets

    Churchill Medical Systems is recalling 2,200 units of 4-inch Microbore Trifurcated Extension Sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.

    Product
    4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2016-2015·2015-04-29

    Ricos Tostaditos Vegetal Skins Recalled for Undeclared Wheat and Soy Oil

    Ricos Tostaditos, Inc. is recalling 150 bags of Ricos Tostaditos Vegetal Skins because the product contains undeclared wheat and soy oil.

    Product
    RICOS Tostaditos Vegetal Skins Imitation Rinds Chicharron Vegetal Hot Crispy and Delicious Net Wt. 3/4 oz. (21g)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-648-2015·2015-04-29

    Attix Pharmaceuticals Recalls Enalapril Maleate Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Enalapril Maleate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Enalapril Maleate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-884-2015·2015-04-29

    Attix Pharmaceuticals Recalls Roflumilast API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Roflumilast active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Roflumilast active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2018-2015·2015-04-29

    Rising Moon Organics Spinach Florentine Ravioli Recalled for Listeria

    Carmel Food Group is recalling Rising Moon Organics Spinach Florentine Ravioli because the spinach used in manufacturing was found to contain Listeria monocytogenes.

    Product
    Rising Moon Organics Spinach Florentine Ravioli; Net Wt 8 oz. (227g) UPC 7 85030 22770 1 Distributed by Rising Moon Organics 313 Iron Horse Way Providence, RI 02908
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-630-2015·2015-04-29

    Attix Pharmaceuticals Recalls Digoxin Ingredient Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Digoxin active pharmaceutical ingredient repackaged between January 2012 and February 2015 due to potential penicillin cross-contamination.

    Product
    Digoxin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-615-2015·2015-04-29

    Attix Pharmaceuticals Recalls Daptomycin API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Daptomycin active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Daptomycin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2011-2015·2015-04-29

    Giant Eagle Recalls GetGo Chicken Salads for Undeclared Wheat

    Giant Eagle is recalling GetGo California Chicken Cobb and Grilled Chicken Salads because they contain undeclared wheat.

    Product
    GETGO Grilled Chicken Salad Sell By: (up to and including 3/26/15) Net Wt: 14 oz. Contains: Soy, Milk, Egg GetGo Giant Eagle Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-847-2015·2015-04-29

    Attix Pharmaceuticals Recalls Polidocanol Due to Penicillin Cross Contamination Risk

    Attix Pharmaceuticals is recalling Polidocanol active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Polidocanol active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-894-2015·2015-04-29

    Silver Sulfadiazine Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Silver Sulfadiazine active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Silver Sulfadiazine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-905-2015·2015-04-29

    Sucralfate API Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling sucralfate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Sucralfate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1489-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects

    Wright Medical Technology is recalling 242 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2R. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-780-2015·2015-04-29

    Attix Pharmaceuticals Recalls Metaxalone API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Metaxalone active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Metaxalone active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2027-2015·2015-04-29

    Dairy Farmers of America Recalls Borden Good 2 Gether Snack Trays

    Dairy Farmers of America is recalling Borden Good 2 Gether snack trays due to a potential hard plastic fragment retained in the packaging.

    Product
    Borden Good 2 Gether, Pepper Jack Cheese & Pretzels, UPC: 5300001114 , Net Wt 2 0z (57 g), Dist. By DFA Dairy Farmers of America, PO Box 909700, Kansas City, MO 64190.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1478-2015·2015-04-29

    Churchill Medical Systems Recalls 6-inch Trifurcated Sets with Bionectors

    Churchill Medical Systems is recalling 1,650 6-inch trifurcated sets with Bionectors due to a potential leak caused by insufficient bonding between the needleless device and the female luer.

    Product
    6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-528-2015·2015-04-29

    Atovaquone API Recalled for Potential Penicillin Cross-Contamination

    Attix Pharmaceuticals is recalling Atovaquone active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Atovaquone active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-618-2015·2015-04-29

    Attix Pharmaceuticals Recalls Demecarium Bromide Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Demecarium Bromide active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Demecarium Bromide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-724-2015·2015-04-29

    Attix Pharmaceuticals Recalls Hydroxyzine HCl Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Hydroxyzine HCl active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Hydroxyzine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-688-2015·2015-04-29

    Flurbiprofen API Recalled for Potential Penicillin Cross-Contamination

    Attix Pharmaceuticals is recalling flurbiprofen active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Flurbiprofen active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1487-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 142 units of the Crosscheck Plating system because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1R. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-666-2015·2015-04-29

    Attix Pharmaceuticals Recalls Etoposide Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Etoposide active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Etoposide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-585-2015·2015-04-29

    Attix Pharmaceuticals Recalls Cilostazol API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling cilostazol active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Cilostazol active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-561-2015·2015-04-29

    Attix Pharmaceuticals Recalls Carbimazole Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Carbimazole active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Carbimazole active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-538-2015·2015-04-29

    Attix Pharmaceuticals Recalls Benoxinate HCl Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Benoxinate HCl active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Benoxinate HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2014-2015·2015-04-29

    Ricos Tostaditos Chiviricos Recalled for Undeclared Wheat and Soy Oil

    Ricos Tostaditos, Inc. is recalling 4,000 bags of Chiviricos Fried Dough due to undeclared wheat and soy oil allergens.

    Product
    RICOS Tostaditos Chiviricos Fried Dough Crispy and Delicious Net Wt. 2-1/4 oz. (64g)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1484-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 128 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left, REF CCP-LPX0L. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-769-2015·2015-04-29

    Attix Pharmaceuticals Recalls Loratadine API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Loratadine active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Loratadine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-778-2015·2015-04-29

    Attix Pharmaceuticals Recalls Memantine HCl Due to Penicillin Cross Contamination Risk

    Attix Pharmaceuticals is recalling Memantine HCl active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Memantine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-581-2015·2015-04-29

    Attix Pharmaceuticals Recalls Chlorpromazine HCl Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Chlorpromazine HCl active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Chlorpromazine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2015·2015-04-29

    Churchill Medical Systems Recalls 4-inch Trifurcated Sets Due to Leaking Risk

    Churchill Medical Systems is recalling 2,650 units of 4-inch trifurcated sets with Bionectors and check valves due to a potential for leaking caused by insufficient bonding.

    Product
    4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-609-2015·2015-04-29

    Attix Pharmaceuticals Recalls Dacarbazine Due to Penicillin Cross Contamination Risk

    Attix Pharmaceuticals is recalling Dacarbazine active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Dacarbazine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-938-2015·2015-04-29

    Attix Pharmaceuticals Recalls Tranexamic Acid Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Tranexamic Acid active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Tranexamic Acid active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2028-2015·2015-04-29

    Dairy Farmers of America Recalls Borden Good 2 Gether Snack Trays

    Dairy Farmers of America is recalling Borden Good 2 Gether Mild Cheddar Cheese & Pretzels snack trays due to a potential hard plastic fragment hazard.

    Product
    Borden Good 2 Gether, Mild Cheddar Cheese & Pretzels, UPC: 5300001111, Net Wt 2 0z (57 g), Dist. By DFA Dairy Farmers of America, PO Box 909700, Kansas City, MO 64190.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1491-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects

    Wright Medical Technology is recalling 301 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-914-2015·2015-04-29

    Attix Pharmaceuticals Recalls Tamsulosin Base Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Tamsulosin Base active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Tamsulosin Base active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-703-2015·2015-04-29

    Attix Pharmaceuticals Recalls Heparin Sodium Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Heparin Sodium active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Heparin Sodium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1500-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 92 units of the Crosscheck Plating system because dimensional specifications are out of range, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2017-2015·2015-04-29

    Rising Moon Organics Garlic and Veggie Ravioli Recalled for Listeria

    Carmel Food Group is recalling Rising Moon Organics Garlic and Veggie Ravioli because the spinach used in manufacturing was found to contain Listeria monocytogenes.

    Product
    Rising Moon Organics Garlic and Veggie Ravioli; Net Wt 8 oz. (227g) UPC 7 85030 00011 3 Distributed by Rising Moon Organics 313 Iron Horse Way Providence, RI 02908
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-909-2015·2015-04-29

    Sumatriptan Succinate Recalled for Potential Penicillin Cross Contamination

    Attix Pharmaceuticals is recalling Sumatriptan Succinate active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Sumatriptan Succinate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2015·2015-04-29

    Churchill Medical Systems Recalls 6-Inch Trifurcated Extension Sets for Leaking Risk

    Churchill Medical Systems is recalling 5,200 6-inch trifurcated extension sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.

    Product
    6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2015·2015-04-29

    Hospira LifeCare PCA Infusion System Recalled for Door Design Flaw

    Hospira is recalling 38,882 LifeCare PCA infusion systems because the clear plastic door design allows excessive flexing, permitting unauthorized access to medication vials.

    Product
    The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1476-2015·2015-04-29

    Churchill Medical Systems Recalls Bifurcated Sets Due to Leaking Risk

    Churchill Medical Systems is recalling 1,050 bifurcated sets with check valves and Bionectors due to a potential for leaking caused by insufficient bonding.

    Product
    Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-608-2015·2015-04-29

    D-Cycloserine API Recalled for Potential Penicillin Cross-Contamination

    Attix Pharmaceuticals is recalling D-Cycloserine active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    D-Cycloserine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-866-2015·2015-04-29

    Attix Pharmaceuticals Recalls Procarbazine HCl Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling Procarbazine HCl active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.

    Product
    Procarbazine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-550-2015·2015-04-29

    Attix Pharmaceuticals Recalls Budesonide API Due to Penicillin Cross-Contamination Risk

    Attix Pharmaceuticals is recalling budesonide active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.

    Product
    Budesonide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2015.