The Recall Desk

Archive

April 2015 recalls

1,319 recalls were announced in April 2015.

What the numbers show

Critical
109
Severe
527
High
388
Moderate
278
Low
17

Of the 1,319 recalls this month scored against our rubric, 8% are Critical, 40% are Severe.

Which agencies issued them

701–800 of 1319

  • ModerateFDA (Devices)·Z-1420-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Contamination

    Nobel Biocare is recalling 74 dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1446-2015·2015-04-22

    Biomet Recalls Low Profile Non-Locking Screws Due to Anodizing Error

    Biomet is recalling 45 Low Profile Non-Locking Screws because they were anodized green instead of the required gold color.

    Product
    LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1440-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

    Nobel Biocare is recalling 38 units of NobelReplace CC PMC RP 5.0x13mm dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2015·2015-04-22

    Actavis Recalls Subpotent Flurandrenolide Tape Products Nationwide

    Actavis is recalling Flurandrenolide Tape products because the active ingredient is subpotent. The recall covers 78,522 cartons distributed in the U.S. and U.K.

    Product
    Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufactured By: 3M Company, St. Paul, MN, 55144. Labeled as A) Cordran Tape, Small Rolls, 24 in x 3 in, NDC: 52544-044-24, B) Cordran Tape, Large Rolls, 80 in x 3 i
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1445-2015·2015-04-22

    Siemens Artis Q and Q zen Angiography Systems Recalled for Electrical Connection

    Siemens is recalling 139 Artis Q and Q zen angiography systems nationwide because an electrical connection in the equipment cabinet may not be installed correctly.

    Product
    Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1411-2015·2015-04-22

    Biomet 3i Recalls Discolored OSSEOTITE Dental Implants

    Biomet 3i is recalling 620 OSSEOTITE dental implants that were discolored due to contact with residual machine fluid.

    Product
    OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0487-2015·2015-04-22

    Apotex Recalls Bromfenac Ophthalmic Solution Due to CGMP Deviations

    Apotex Inc. is recalling 33,795 bottles of Bromfenac Ophthalmic Solution 0.09% because an excipient was not re-tested at the appropriate date.

    Product
    Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0489-2015·2015-04-22

    Cardinal Health Recalls Potassium Chloride Tablets Due to Incorrect Package Insert

    Cardinal Health is recalling specific lots of potassium chloride extended-release tablets because they were packaged with the wrong package insert.

    Product
    Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated shipper, Rx only, Manufactured by Upsher-Smith Laboratories, Inc. Minneapolis, MN 55447 for Sandoz, Inc., Princeton, NJ 08540 Repackaged by Cardinal Health Zanesvil
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·15V235000·2015-04-21

    Starcraft RV Recalls 2016 Autumn Ridge Trailers Due to Wheel Stud Defect

    Starcraft RV is recalling 34 model year 2016 Autumn Ridge trailers because wheel studs may break, potentially causing the wheel to detach and increasing crash risk.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT AUTUMN RIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V238000·2015-04-21

    Highland Ridge RV Recalls 2016 Trailers Due to Wheel Stud Defect

    Highland Ridge RV is recalling 2016 Mesa Ridge, 3X, and Roamer travel trailers and fifth wheels because wheel studs may break, potentially causing the wheel to detach.

    Product
    HIGHLAND RIDGE FW — HIGHLAND RIDGE FW, HIGHLAND RIDGE TT 3X, ROAMER, MESA RIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·15117·2015-04-21

    Lenovo Recalls ThinkPad Notebook Computer Battery Packs Due to Fire Hazard

    Lenovo is recalling ThinkPad notebook computer battery packs because they can overheat and pose a fire hazard. Consumers should remove the battery and contact Lenovo for a free replacement.

    Product
    ThinkPad notebook computer battery packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·15118·2015-04-21

    Trek Recalls Bicycles with Front Disc Brakes Due to Crash Hazard

    Trek is recalling about 900,000 U.S. bicycles equipped with front disc brakes because the quick release lever can contact the brake, causing sudden stops or wheel separation.

    Product
    Trek bicycles equipped with front disc brakes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V236000·2015-04-21

    Toyota Recalls 2015 Siennas for Potential Trim Panel Detachment Risk

    Toyota is recalling 2015 Siennas with dealer-installed entertainment systems because a reused clip may allow a trim panel to detach during airbag deployment.

    Product
    TOYOTA — TOYOTA SIENNA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15116·2015-04-21

    Gorsuch Recalls Ertlrenz Ski Boot Heat Liners Due to Fire Hazard

    Gorsuch is recalling Ertlrenz ski boot heat liners because they can overheat while charging, posing a fire hazard. No injuries have been reported.

    Product
    Ertlrenz Trim Heat and Foam Heat ski boot liners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V237000·2015-04-21

    Coachmen Freelander and Leprechaun Recalled for Incorrect Weight Labels

    Forest River is recalling 2015-2016 Coachmen Freelander and 2015 Leprechaun vehicles because incorrect weight labels may lead to overloading and increased crash risk.

    Product
    COACHMEN — COACHMEN FREELANDER, LEPRECHAUN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15119·2015-04-21

    AG Hair Sweet Heat Hair Dryers Recalled for Electrocution Hazard

    AG Hair is recalling about 3,100 Sweet Heat hair dryers because they lack an immersion protection device, posing an electrocution risk if submerged in water.

    Product
    Sweet Heat Hair Dryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V231000·2015-04-20

    Forest River Recalls 2016 Trailers Due to Wheel Stud Failure Risk

    Forest River is recalling 691 model year 2016 trailers because wheel studs may break, potentially causing the wheel to detach and increasing crash risk.

    Product
    AMERA-LITE — AMERA-LITE, US CARGO, AMERALITE WATTX, PHANTOM, TRAIL MASTER, ATTX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V233000·2015-04-20

    Mitsubishi Recalls Lancer and Outlander Models for Blower Motor Defect

    Mitsubishi is recalling 76,958 vehicles because a blower motor failure may reduce windshield defroster performance, increasing crash risk.

    Product
    MITSUBISHI — MITSUBISHI LANCER SPORTBACK, OUTLANDER SPORT, LANCER EVOLUTION, LANCER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15E030000·2015-04-20

    Cummins Westport ISL G Engine Recall for Fire Risk

    Cummins is recalling Westport ISL G engines because excessive crankcase pressure may cause a vent tube to detach, allowing oil to contact hot surfaces and increase fire risk.

    Product
    ENGINE AND ENGINE COOLING:ENGINE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V232000·2015-04-20

    Mitsubishi Recalls Lancer and Outlander Models for Electrical Control Unit Defect

    Mitsubishi is recalling certain 2009-2010 Lancer, Outlander, Lancer Sportback, and Lancer Evolution vehicles because an unstable voltage in the electronic control unit may cause lights and wipers to fail, increasing crash risk.

    Product
    MITSUBISHI — MITSUBISHI LANCER, OUTLANDER, LANCER EVOLUTION, LANCER SPORTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·066-2015·2015-04-20

    Kayem Foods Recalls Chicken Sausage Due to Plastic Contamination

    Kayem Foods is recalling approximately 59,203 pounds of fully cooked chicken sausage products that may contain pieces of plastic.

    Product
    Kayem Foods Inc. — Kayem Foods Recalls Sausage Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·065-2015·2015-04-20

    Michigan Brand Recalls Smoked Turkey and Beef for Labeling Error

    Michigan Brand, Inc. is recalling approximately 737 pounds of smoked turkey and beef products because the labels failed to list sodium nitrite as an ingredient.

    Product
    Michigan Brand, Inc. — Recall Notification Report 065-2015 (Turkey and Beef)
    Category
    Food
    Distribution
    1 state
  • CriticalUSDA FSIS·064-2015·2015-04-18

    B & R Meat Processing Recalls Pork Products Due to Staphylococcal Enterotoxin

    B & R Meat Processing is recalling approximately 2,129 pounds of pork products due to a processing deviation that may have led to staphylococcal enterotoxin contamination.

    Product
    B & R Meat Processing — B & R Meat Processing Recalls Pork Products Due to Possible Processing Deviation and Staphylococcal Enterotoxin Contamination
    Category
    Food
    Distribution
    1 state
  • CriticalUSDA FSIS·063-2015·2015-04-17

    Royal Frozen Food Recalls Beef and Chicken Blintzes Due to Undeclared Milk

    Royal Frozen Food is recalling beef and chicken blintzes because they contain undeclared milk, a known allergen. The products were distributed in California and Nevada.

    Product
    Royal Frozen Food — Royal Frozen Food Recalls Beef and Chicken Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·15V228000·2015-04-17

    Toyota Recalls 2015 Scion tC for Rear Suspension Tightening Defect

    Toyota is recalling 114 model year 2015 Scion tC vehicles because rear suspension components may not have been properly tightened, increasing the risk of a crash.

    Product
    SCION — SCION TC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V227000·2015-04-17

    Highland Ridge RV Recalls 2015 Residential Trailers Due to Gas Line Defect

    Highland Ridge RV is recalling 2015 Residential 417RS fifth wheel trailers because a short gas line may leak when the kitchen slideout is expanded, increasing fire risk.

    Product
    HIGHLAND RIDGE FW — HIGHLAND RIDGE FW RESIDENTIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V226000·2015-04-17

    Nissan Recalls Infiniti Vehicles for Air Bag Inflator Rupture Risk

    Nissan is recalling specific Infiniti models because the passenger air bag inflator may rupture during deployment, potentially causing serious injury or death.

    Product
    INFINITI — INFINITI FX35, FX45, I35, M35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V229000·2015-04-17

    Volkswagen and Audi Recall 2015 Models for Fuel Pump Defect

    Volkswagen Group of America is recalling 2015 Golf, GTI, and Audi A3 vehicles because a fuel pump defect may cause the engine to stall, increasing crash risk.

    Product
    AUDI — AUDI, VOLKSWAGEN A3 CABRIOLET, GOLF, GTI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·15114·2015-04-16

    Civia Cycles Recalls Hyland Bicycles and Fenders Due to Crash Hazard

    Civia Cycles is recalling approximately 1,000 Hyland bicycles and aluminum fender sets because the mounting brackets can break, posing a fall hazard to riders.

    Product
    Hyland Bicycles and Aluminum Fenders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15729·2015-04-16

    Toro Recalls 2015 Walk-Behind Mowers Due to Blade Injury Hazard

    The Toro Company is recalling 2015 22-inch walk-behind mowers because an incorrect blade driver can cause the blade to break, posing an injury risk.

    Product
    Walk behind power mower
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15115·2015-04-16

    Gena Accessories Recalls Silk Scarves Due to Burn Hazard

    Gena Accessories is recalling about 9,400 women's silk scarves because they fail to meet federal flammability standards, posing a burn hazard.

    Product
    Silk scarves
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-454-2015·2015-04-15

    CAPS Recalls Trophamine IV Infusion Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling Trophamine IV infusion bags because they failed sterility tests for microbial contamination.

    Product
    St Lukes East Lees Summit (MO) Protein Bag,Trophamine 5g, Dextrose 10%, Additives: Calcium Gluconate 4.65mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS,
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0433-2015·2015-04-15

    Hospira Recalls MitoXANTRONE Injection Due to Stability Failures

    Hospira Inc. is recalling MitoXANTRONE Injection vials because the product failed stability specifications, resulting in subpotent medication and out-of-specification impurities.

    Product
    MITOXANTRONE — MITOXANTRONE (MITOXANTRONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-467-2015·2015-04-15

    CAPS Recalls Neonatal TPN Bags Due to Sterility Test Failures

    Central Admixture Pharmacy Services is recalling five bags of neonatal TPN due to out-of-specification sterility test results.

    Product
    Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM, Trophamine 4g/dL, Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1907-2015·2015-04-15

    H-E-B Tortilla Soup Recalled for Undeclared Peanuts

    H-E-B is recalling single-serving tortilla soup sold in Texas due to undeclared peanuts, posing a risk to individuals with peanut allergies.

    Product
    H-E-B Single Serving Tortilla Soup 8 oz. and 16 oz. and purchased from the hot soup kettle at the Deli/Prepared Foods Counter purchased on or before 01/06/2015
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1908-2015·2015-04-15

    H-E-B Poblano Corn Chowder Recalled for Undeclared Peanuts

    H-E-B is recalling Poblano Corn Chowder sold in Texas due to undeclared peanuts. Consumers with peanut allergies should not eat the product.

    Product
    H-E-B Single Serving Poblano Corn Chowder 8 oz. and 16 oz. and purchased from the hot soup kettle at the Deli/Prepared Foods Counter purchased on or before 01/06/2015
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-449-2015·2015-04-15

    FDA Recalls Non-Sterile Neonatal TPN Bags Due to Microbial Contamination

    Central Admixture Pharmacy Services is recalling 10 bags of neonatal TPN due to failed sterility tests indicating microbial contamination.

    Product
    Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-437-2015·2015-04-15

    CAPS Recalls 20 Bags of TPN Neonatal Starter Bag for Sterility Failure

    Central Admixture Pharmacy Services is recalling 20 bags of University of Alabama Birmingham TPN Neonatal Starter Bag due to out-of-specification sterility test results.

    Product
    University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box. each container is lined with a polystyrene insert; CAPS, Allentown, PA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1882-1015·2015-04-15

    Texamerican Roast Dip Seasoning Recalled for Undeclared Peanut Allergen

    Texamerican Food Blending is recalling 20,000 pounds of Roast Dip Seasoning because two ingredient lots were contaminated with peanut allergen, which is not listed on the label.

    Product
    Texamerican Roast Dip Seasoning 50 lbs. Item Number TF25004
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-458-2015·2015-04-15

    CAPS Recalls Neonatal IV Infusion Bags Due to Sterility Test Failures

    Central Admixture Pharmacy Services is recalling 4 bags of compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.

    Product
    Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine 5%, Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-455-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Non-Sterile TPN Infusion Bags

    Central Admixture Pharmacy Services is recalling five bags of Truman Medical Center Lakewood Starter TPN due to out-of-specification sterility test results indicating microbial contamination.

    Product
    Truman Medical Center Lakewood (MO) Starter TPN, Trophamine 5.25g, Dextrose 10%, Additives: Calcium Gluconate 4.8mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene inser
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1876-2015·2015-04-15

    Texamerican Chili Powder Recalled for Undeclared Peanut Allergen

    Texamerican Food Blending is recalling specific lots of chili powder because ingredients were contaminated with peanut allergen, which is not listed on the label.

    Product
    Texamerican Chili Powder: 5 lbs. Item Number: ARCH064-50; 10 lbs. Item Number: TF5002 (R&D only).
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1888-2015·2015-04-15

    Seattle Pops Arroz con Leche Frozen Pops Recalled for Listeria Risk

    Seattle Pops is recalling Arroz con Leche Frozen Pops due to potential Listeria monocytogenes contamination from an ice cream ingredient.

    Product
    Arroz con Leche Frozen Pops, 4.0 fl oz. frozen pop is individually packaged in a sealed plastic bag; 24 pops/case. Product is labeled in part, "***rice, cinnamon, vanilla, cream, milk, skim milk powder, non-gmo cane sugar, less than 0.4% stabilizer (carob bean gum, guar gum, so
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-439-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Compounded IV Infusion Bags

    Central Admixture Pharmacy Services is recalling 8 bags of compounded IV infusion bags due to out-of-specification sterility test results.

    Product
    Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-456-2015·2015-04-15

    CAPS Recalls Trophamine UAC Solution Due to Sterility Test Failures

    Central Admixture Pharmacy Services is recalling Trophamine UAC Solution because it failed sterility tests for microbial contamination.

    Product
    Truman Medical Center Lakewood (MO) Trophamine UAC Solution, Trophamine 3.2g, compound vol: 100 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F1877-2015·2015-04-15

    Texamerican Jalapeno Seasoning Recalled for Undeclared Peanut Allergen

    Texamerican Food Blending, Inc. is recalling 100 pounds of Jalapeno Seasoning because it was contaminated with peanut allergen not listed on the label.

    Product
    Texamerican Jalapeno Seasoning 50 lbs. Item Number: TF1422701 (R&D only)
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-452-2015·2015-04-15

    Recall of Compounded TPN Bags Due to Sterility Test Failures

    Central Admixture Pharmacy Services is recalling five bags of compounded Total Parenteral Nutrition (TPN) because they failed sterility tests for microbial contamination.

    Product
    Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dextrose 20g, Additives: Calcium Gluconate 8mEq, compound vol: 200 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-468-2015·2015-04-15

    FDA Recalls Two Bags of Neonatal TPN Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling two bags of a compounded neonatal TPN product because sterility testing failed. The product was distributed nationwide.

    Product
    Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Trophamine 5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46 mEq/mL, 750mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each contai
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1903-2015·2015-04-15

    Santa Barbara Smokehouse Recalls Smoked Salmon Due to Listeria

    The Santa Barbara Smokehouse is recalling specific batches of smoked salmon because samples tested positive for Listeria monocytogenes.

    Product
    Oakwood and Applewood smoked salmon under the following brands; Cambridge House Royal Sliced Side SKU: 8 30859 01002 4, Cambridge House Royal Prime Tenderloin SKU: 8 30859 01001 7 All products are vacuum packed and are either fresh or frozen. Products are cold smoked.
    Category
    Food
    Distribution
    17 states
  • CriticalFDA (Drugs)·D-466-2015·2015-04-15

    Central Admixture Pharmacy Recalls Compounded IV Infusion Bags for Sterility Failure

    Central Admixture Pharmacy Services is recalling specific compounded IV infusion bags due to out-of-specification sterility test results indicating microbial contamination.

    Product
    Bayshore Medical Center (TX) 5% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 5%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each contain
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-444-2015·2015-04-15

    FDA Recalls Compounded Neonatal IV Infusion Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.

    Product
    Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 2% Dex10%, Trophamine 2% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a p
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-461-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags

    Central Admixture Pharmacy Services is recalling four bags of neonatal TPN due to sterility test failures. The product was distributed nationwide.

    Product
    Abington Memorial Hospital (PA) TPN Neonatal Starter 0.6-0.99 Kg, Amino Acids, Neonate 5g, Dextrose 7.5%, 250 ml, Additives: heparin PF 125 unit(s)/ml, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corr
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-442-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags

    Central Admixture Pharmacy Services is recalling four bags of neonatal TPN solution due to failed sterility tests indicating microbial contamination.

    Product
    Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 4mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-441-2015·2015-04-15

    CAPS Recalls Neonate Starter IV Infusion Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling two bags of Neonate Starter IV infusion bags because they failed sterility tests for microbial contamination.

    Product
    The Medical Center of Aurora (CO) Neonate Starter 2% AA/D10W, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-462-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls TPN Neonatal Starter Bags

    Central Admixture Pharmacy Services is recalling TPN Neonatal Starter IV infusion bags due to out-of-specification sterility test results.

    Product
    Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additives: heparin PF 75 units, Calcium Gluconate 300mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-469-2015·2015-04-15

    FDA Recalls Two Bags of Neonatal TPN Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling two bags of neonatal TPN bags due to out-of-specification sterility test results.

    Product
    Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm , Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-440-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Neonate D5 Bridge IV Infusion Bags

    Central Admixture Pharmacy Services is recalling two bags of a neonatal IV infusion bag due to out-of-specification sterility test results.

    Product
    Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS,
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1897-2015·2015-04-15

    Santa Barbara Smokehouse Recalls Smoked Salmon Pastrami Due to Listeria

    The Santa Barbara Smokehouse is recalling specific batches of smoked salmon pastrami because environmental and finished product samples tested positive for Listeria monocytogenes.

    Product
    Oak & Beechwood smoked salmon pastrami sliced side under the following brand; Coastal Harbor SKU: 8 30859 01450 3 All products are vacuum packed and are either fresh or frozen. Products are cold smoked. A gold sticker is placed directly on the vacuum package of flavored smok
    Category
    Food
    Distribution
    17 states
  • CriticalFDA (Drugs)·D-465-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Non-Sterile TPN Infusion Bags

    Central Admixture Pharmacy Services is recalling 3 bags of compounded TPN infusion bags due to non-sterility test failures.

    Product
    Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each conta
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1898-2015·2015-04-15

    Santa Barbara Smokehouse Recalls Smoked Salmon for Listeria Contamination

    The Santa Barbara Smokehouse is recalling specific batches of smoked salmon because samples tested positive for Listeria monocytogenes.

    Product
    Oakwood and whiskey smoked salmon sliced sides and whole sides under the following brands; Balmoral SKU: 8 30859 03363 4, Private Reserve Rope Hung 4oz SKU: 8 30859 01034 5, Private Reserve Rope Hung SKU: 8 30859 01030 7 All products are vacuum packed and are either fresh or
    Category
    Food
    Distribution
    17 states
  • CriticalFDA (Drugs)·D-460-2015·2015-04-15

    FDA Recalls 20 Neonatal TPN Bags Due to Sterility Test Failures

    Central Admixture Pharmacy Services is recalling 20 neonatal TPN bags because sterility tests showed microbial contamination.

    Product
    Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 200mg/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each contain
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-443-2015·2015-04-15

    FDA Recalls Compounded Neonatal IV Infusion Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling two bags of compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.

    Product
    Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 4%Dex5% ,Trophamine 4% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a poly
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-470-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls TPN Neonatal Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling 12 bags of Virginia Hospital Center TPN Neonatal Day 1 Bags due to out-of-specification sterility test results indicating microbial contamination.

    Product
    Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1895-2015·2015-04-15

    Santa Barbara Smokehouse Recalls Smoked Salmon Due to Listeria

    The Santa Barbara Smokehouse is recalling specific batches of smoked salmon because samples tested positive for Listeria monocytogenes.

    Product
    Oakwood and Whiskey smoked salmon sliced sides under the following brands; Cambridge House SKU: 8 30859 01163 2, Coastal Harbor SKU: 8 30859 01369 8 All products are vacuum packed and are either fresh or frozen. Products are cold smoked.
    Category
    Food
    Distribution
    17 states
  • CriticalFDA (Food)·F-1899-2015·2015-04-15

    Santa Barbara Smokehouse Recalls Smoked Salmon Pastrami Due to Listeria

    The Santa Barbara Smokehouse is recalling smoked salmon pastrami because environmental and finished product samples tested positive for Listeria monocytogenes.

    Product
    Smoked salmon pastrami sliced side under the following brand; Cambridge House Royal SKU: 8 30859 01013 0 All products are vacuum packed and are either fresh or frozen. Products are cold smoked. A gold sticker is placed directly on the vacuum package of flavored smoked salmo
    Category
    Food
    Distribution
    17 states
  • CriticalFDA (Drugs)·D-448-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls NICU TPN Starter Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling a specific lot of NICU TPN Starter IV bags because sterility tests showed microbial contamination.

    Product
    Olathe Medical Center (KS) NICU TPN Starter: Ingredients per 80 ml, Trophamine 3g Dextrose 10%, Additives: Calcium Gluconate 250mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a pol
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1883-2015·2015-04-15

    Texamerican Glaze Mix Recalled for Undeclared Peanut Allergen

    Texamerican Food Blending is recalling 25-pound bags of Glaze Mix because ingredients were contaminated with peanut allergen, which is not listed on the label.

    Product
    Texamerican Glaze Mix 25 lbs. Item Number TF2710901
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-445-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Compounded TPN Infusion Bags

    Central Admixture Pharmacy Services is recalling 4 bags of compounded TPN infusion bags due to non-sterility test failures.

    Product
    Advocate Good Samaritan Hospital (IL) TPN Dextrose 5% Trophamine 2%, Trophamine 5% Dextrose 2%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown,
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-446-2015·2015-04-15

    CAPS Recalls Compounded TPN Infusion Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling four bags of compounded TPN infusion bags because they failed sterility tests for microbial contamination.

    Product
    Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown,
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-438-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls TPN Neonate Starter Bags for Sterility Issues

    Central Admixture Pharmacy Services is recalling 10 bags of TPN Neonate Starter Bags due to out-of-specification sterility test results indicating microbial contamination.

    Product
    Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, Trophamine 4% Dextrose 10%, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allen
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-464-2015·2015-04-15

    CAPS Recalls Lankenau Hospital TPN Neonatal Starter Bags for Sterility Failure

    Central Admixture Pharmacy Services is recalling six Lankenau Hospital TPN Neonatal Starter Bags due to out-of-specification sterility test results.

    Product
    Lankenau Hospital (PA) TPN Neonatal Starter Bag, Trophamine 2.5%, Dextrose 10%, Additives: heparin PF 62.5 units, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined wit
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1894-2015·2015-04-15

    Santa Barbara Smokehouse Recalls Smoked Salmon Due to Listeria

    The Santa Barbara Smokehouse is recalling specific batches of smoked salmon because environmental and finished product samples tested positive for Listeria monocytogenes.

    Product
    Beechwood Smoked and Atlantic Salmon sliced sides, whole sides, and trimmings under the following brands; Coastal Harbor SKU: 8 30859 01183 0, Channel Island SKU: 8 30859 03093 0, Atlantic Smoked SKU: 8 30859 01253 0, Harbor Point SKU: 8 30859 01515 9, Local Abundance SKU: 8 3085
    Category
    Food
    Distribution
    17 states
  • CriticalFDA (Food)·F-1884-2015·2015-04-15

    Seattle Pops Recalls Kona Coffee Frozen Pops for Listeria Risk

    Seattle Pops is recalling Kona Coffee Frozen Pops because they contain an ice cream ingredient potentially contaminated with Listeria monocytogenes.

    Product
    Kona Coffee Frozen Pops 4.0 fl oz. frozen pop is individually packaged in a sealed plastic bag; 24 pops/case. Product is labeled in part, "***dark roast 100% kona coffee, cream, milk, skim milk powder, non-gmo cane sugar, less than 0.4% stabilizer (carob bean gum, guar gum, so
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1879-2015·2015-04-15

    Texamerican Cumin Recalled Due to Undeclared Peanut Allergen

    Texamerican Food Blending is recalling 5 lb. bags of Cumin because two lots of ingredients were contaminated with peanut allergen, which is not listed on the label.

    Product
    Texamerican Cumin 5 lbs. Item Number: ARCH075-05
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1896-2015·2015-04-15

    Santa Barbara Smokehouse Recalls Smoked Salmon Due to Listeria Contamination

    The Santa Barbara Smokehouse is recalling 1,018 lbs of Cambridge House Royal smoked salmon because samples tested positive for Listeria monocytogenes.

    Product
    Smoked salmon lemon dill sliced side under the following brand; Cambridge House Royal SKU: 8 30859 01018 5 All products are vacuum packed and are either fresh or frozen. Products are cold smoked. A gold sticker is placed directly on the vacuum package of flavored smoked sal
    Category
    Food
    Distribution
    17 states
  • CriticalFDA (Food)·F-1890-2015·2015-04-15

    California Snack Foods Recalls Caramel Apples Due to Listeria Risk

    California Snack Foods Inc. is recalling Karm'l Dapple caramel apples because they may be associated with a Listeria monocytogenes outbreak.

    Product
    Karm'l Dapple; Net Wt. 4 oz. (124g) Brown/Peanuts. Sold in Single size and 3 pack (12 oz. (340g) and Halloween Ingredients: Fresh Selected Apples, Sugar, Water Corn Syrup, Nonfat Dry Milk Solids, Cottonseed shortening and/or soybean oil, corn and soy cereal parts, flour, sal
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-1926-2015·2015-04-15

    Garden Lites Southwestern Souffle Recalled for Undeclared Peanut Protein

    Classic Cooking LLC is recalling Garden Lites Southwestern Souffle because it contains undeclared peanut protein. Consumers should not eat the product.

    Product
    garden lites Southwestern Souffle, NET WT 7 oz (198g), UPC 7-04863-01720-4
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-447-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Compounded TPN Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling three bags of compounded TPN due to out-of-specification sterility test results indicating microbial contamination.

    Product
    Methodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dextrose 5%, Additives: heparin PF 100 units/mL, 50 units/dL, Calcium Gluconate 0.46 mEq/mL, 200 mg/dL, compound vol: 300 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corru
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-450-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags

    Central Admixture Pharmacy Services is recalling four bags of neonatal TPN due to non-sterility test failures. The product was distributed nationwide.

    Product
    Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; C
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-459-2015·2015-04-15

    CAPS Recalls Neonatal IV Infusion Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling two bags of a neonatal IV infusion compound because sterility testing failed.

    Product
    Robert Wood Johnson University (NJ) Neonatal Starter 5% Dextrose, Trophamine 5%, Dextrose 5%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1928-2015·2015-04-15

    Garden Lites Veggie Bites Recalled for Undeclared Peanut Protein

    Classic Cooking LLC is recalling Garden Lites Veggie Bites Kale & Brown Rice because the product contains undeclared peanut protein.

    Product
    Garden Lites Veggie Bites Kale & Brown Rice, NET WT 9 oz (225g). UPC 7-04863-03611-3. KEEP FROZEN. 12 BITES.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-463-2015·2015-04-15

    FDA Recalls Six Bags of Neonatal TPN Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling six bags of compounded neonatal TPN because sterility tests failed. The product was distributed nationwide.

    Product
    Abington Memorial Hospital (PA) TPN Neonatal Starter> 1Kg, Amino Acids, Neonate 12.5g, Dextrose 10%, 500 ml, Additives: heparin PF 250 units, Calcium Gluconate 1250mg, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1930-2015·2015-04-15

    Garden Lites Veggie Chili & Cornbread Melt Recalled for Undeclared Peanut

    Classic Cooking LLC is recalling Garden Lites Veggie Chili & Cornbread Melt because it contains undeclared peanut protein.

    Product
    garden lites Veggie Chili & Cornbread Melt, Net WT 7 oz (198g). UPC 7-04863-01726-6. KEEP FROZEN.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-457-2015·2015-04-15

    FDA Recalls Non-Sterile Compounded Neonatal IV Infusion Bags

    Central Admixture Pharmacy Services is recalling 10 bags of compounded neonatal IV solution due to sterility test failures.

    Product
    Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine 3%, Dextrose 5%, Additives: Calcium Gluconate 0.46mEq/mL, 7mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1927-2015·2015-04-15

    Garden Lites Kale & Quinoa Souffle Recalled for Undeclared Peanut

    Classic Cooking LLC is recalling Garden Lites Kale & Quinoa Souffle because it contains undeclared peanut protein, posing a risk to individuals with peanut allergies.

    Product
    Garden Lites Kale & Quinoa Souffle, NET WT 7 oz, UPC 7-04863-01730-3
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-453-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls Neonate TPN Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling six bags of neonate TPN starter bags due to out-of-specification sterility test results indicating microbial contamination.

    Product
    Providence Hospital Southfield (MI) Neonate TPN Starter Bag, Trophamine 3g, Dextrose 10%, Additives: heparin PF 0.5 unit(s)/mL, Calcium Gluconate 600mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each containe
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-451-2015·2015-04-15

    Central Admixture Pharmacy Services Recalls TPN Bags Due to Sterility Failure

    Central Admixture Pharmacy Services is recalling 5 bags of Total Parenteral Nutrition (TPN) compounded for Walter Reed National Military Medical Center because sterility tests failed.

    Product
    Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% without Ca, Trophamine 12g, Dextrose 20g, compound vol: 200 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1901-2015·2015-04-15

    Santa Barbara Smokehouse Recalls Smoked Salmon for Listeria

    The Santa Barbara Smokehouse is recalling Oakwood mild smoked salmon lemon pepper due to Listeria monocytogenes contamination.

    Product
    Oakwood mild smoked salmon lemon pepper sliced side under the following brand; Cambridge House SKU: 8 30859 01086 4 All products are vacuum packed and are either fresh or frozen. Products are cold smoked. A gold sticker is placed directly on the vacuum package of flavored
    Category
    Food
    Distribution
    17 states
  • CriticalFDA (Food)·F-1886-2015·2015-04-15

    Seattle Pops Cinnamon Frozen Pops Recalled for Listeria Risk

    Seattle Pops is recalling Cinnamon Frozen Pops because they contain an ice cream ingredient potentially contaminated with Listeria monocytogenes.

    Product
    Cinnamon Frozen Pops, 4.0 fl oz. frozen pop is individually packaged in a sealed plastic bag; 24 pops/case. Product is labeled in part, "***cream, milk, skim milk powder, non-gmo cane sugar, vanilla, cinnamon, less than 0.4% stabilizer (carob bean gum, guar gum, soy lecithin, c
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1909-2015·2015-04-15

    H-E-B Gumbo Recalled for Undeclared Peanuts in Texas

    H-E-B Houston Culinary Center is recalling specific gumbo products sold in Texas due to undeclared peanuts. The recall is voluntary and classified as Class I by the FDA.

    Product
    H-E-B Single Serving Gumbo 8 oz.; H-E-B Houston Culinary Center Gumbo - Bulk 2/10 lb poly bags
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1917-2015·2015-04-15

    Nu Products Seasoning Recalls Sazon and Taco Seasoning for Peanut Contamination

    Nu Products Seasoning Co. is recalling Sazon High Color and Taco Seasoning because they may contain peanut protein from ground cumin.

    Product
    NuSpice Sazon High Color Seasoning - F2111, Net Wt: 50 lb, Manufacturer: Nu Products Seasoning Co., 74 Louis Court, South Hackensack, N.J. 07606
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1905-2015·2015-04-15

    Santa Barbara Smokehouse Recalls Smoked Salmon Due to Listeria

    The Santa Barbara Smokehouse is recalling smoked wild Pacific salmon because samples tested positive for Listeria monocytogenes.

    Product
    Oakwood smoked wild pacific salmon sliced side under the following brand; Sustainable Rope Hung SKU: 8 30859 03287 3 All products are vacuum packed and are either fresh or frozen. Products are cold smoked.
    Category
    Food
    Distribution
    17 states
  • CriticalFDA (Food)·F-1878-2015·2015-04-15

    Flavor Source Taco Seasoning Recalled for Undeclared Peanut Allergen

    Texamerican Food Blending is recalling specific lots of Flavor Source Taco Seasoning because ingredients were contaminated with undeclared peanut allergen.

    Product
    Flavor Source Taco Seasoning 50 lbs. and 10 lbs. Item Number: FS1405005 (R&D only); and 5 lbs. Item Number: FS1405002 (R&D only)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1910-2015·2015-04-15

    H-E-B Texas Ranch Casserole Recalled for Undeclared Peanuts

    H-E-B Houston Culinary Center is recalling Texas Ranch Casserole products in Texas due to undeclared peanuts.

    Product
    H-E-B Single Serving Texas Ranch Casserole 8 oz. and 16 oz.; H-E-B Houston Culinary Center Texas Ranch Casserole - Bulk 22.6 lb
    Category
    Food
    Distribution
    1 state

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