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2014 news from the US Food and Drug Administration.
Click title to see the full article at the FDA
website. For the most up-to-date headlines, check out the FDA
Newsroom. Press announcements from 2004 to 2009 are available through
the FDA
Archive.
| English |
| December 23, 2014 - FDA
approves weight-management drug Saxenda |
| December 23, 2014 - FDA
Commissioner Margaret A. Hamburg's statement on FDA’s blood donor
deferral policy for men who have sex with men |
| December 22, 2014 - FDA
approves Opdivo for advanced melanoma |
| December 22, 2014 - FDA
approves Rapivab to treat flu infection |
| December 19, 2014 - FDA
approves new antibacterial drug Zerbaxa |
| December 19, 2014 - FDA
approves Viekira Pak to treat hepatitis C |
| December 19, 2014 - FDA
approves Lynparza to treat advanced ovarian cancer |
| December 19, 2014 - FDA
approves pathogen reduction system to treat platelets |
| December 17, 2014 - FDA
approves Xtoro to treat swimmer’s ear |
| December 16, 2014 - FDA
approves first pathogen reduction system to treat plasma |
| December 16, 2014 - FDA
announces Pharmacy Compounding Advisory Committee members |
| December 15, 2014 - FDA
allows marketing of the first newborn screening test to help detect
Severe Combined Immunodeficiency |
| December 15, 2014 - FDA
clears test that helps predict the risk of coronary heart disease |
| December 15, 2014 - FDA
grants CLIA waiver expanding the availability of rapid screening test
for syphilis |
|
December 12, 2014 - FDA
expands approved use of Cyramza to treat aggressive non-small cell
lung cancer
|
|
December 12, 2014 - RZM
Food Factory to cease operations for repeated food safety violations
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December 11, 2014 - FDA
approves first test to confirm the presence of Human T-cell Lymphotropic
Virus-I/II antibodies
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December 10, 2014 - FDA
approves Gardasil 9 for prevention of certain cancers caused by
five additional types of HPV
|
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December 08, 2014 -
OtisMed Corporation, former CEO plead guilty for distributing FDA-rejected
cutting guides for knee replacement surgeries
|
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December 04, 2014 - FDA
resolves criminal and civil actions against Main Street Family Pharmacy
|
| December 04, 2014 -
FDA approves Jakafi to treat patients with a chronic type of bone
marrow disease |
| December 04, 2014 -
California seafood company to halt production until FDA documents
correction of unsanitary practices |
| December 03, 2014 - FDA
approves Blincyto to treat a rare form of acute lymphoblastic leukemia |
|
December 03, 2014 - FDA
issues final rule on changes to pregnancy and lactation labeling
information for prescription drug and biological products
|
| English |
| October 29, 2014 - First
vaccine approved by FDA to prevent serogroup B Meningococcal disease |
| October 24, 2014 - FDA
approves new treatment for rare form of hemophilia |
| October 17, 2014 - FDA
approves labeling with abuse-deterrent features for third extended-release
opioid analgesic |
| October 15, 2014 - FDA
approves Ofev to treat idiopathic pulmonary fibrosis |
| October 15, 2014 - FDA
approves Esbriet to treat idiopathic pulmonary fibrosis |
| October 14, 2014 - Federal
judge approves FDA consent decree with Ascend Laboratories |
| October 14, 2014 - FDA
permits marketing of urinary prosthesis device for women |
| October 10, 2014 - FDA
approves a new ultrasound imaging agent |
| October 10, 2014 - FDA
approves first combination pill to treat hepatitis C |
| October 10, 2014 - FDA
approves first drug-coated angioplasty balloon catheter to treat vascular
disease |
| October 10, 2014 - FDA
approves Akynzeo for nausea and vomiting associated with cancer chemotherapy |
|
October 03, 2014 - FDA
seeks permanent injunction against Pharmaceutical Innovations, Inc.
|
|
October 01, 2014 - The
FDA takes steps to strengthen cybersecurity of medical devices
|
| English |
| September 30, 2014 - FDA
awards grants to stimulate drug, device development for rare diseases |
| September 25, 2014 - U.S.
Marshals seize botanical substance kratom from southern California
facility |
| September 25, 2014 - NIH
and FDA win top award for intellectual property licensing of meningitis
vaccine |
| September 24, 2014 - FDA
clears glucose monitoring system for use in hospital critical care
units |
| September 23, 2014 - FDA
food safety challenge to spur new technologies for fighting foodborne
illness |
| September 22, 2014 - FDA
allows marketing of the first test to identify five yeast pathogens
directly from a blood sample |
| September 19, 2014 - FDA
releases updated proposals to improve food safety and help prevent
foodborne illness in response to public comments |
| September 18, 2014 - FDA
approves Trulicity to treat type 2 diabetes |
| September 16, 2014 - FDA
approves Movantik for opioid-induced constipation |
| September 10, 2014 - FDA
approves weight-management drug Contrave |
| September 09, 2014 - FDA
reminds health care professionals and consumers not to use sterile
products from Downing Labs/NuVision Pharmacy of Texas |
| September 6, 2014 - Pharmacy
Creations Issues Voluntary Recall of Four Product Lots With Limited
Distribution in Florida, New Jersey, New York, and Puerto Rico Due
to Potential Non-Sterility |
| September 05, 2014 - FDA
allows marketing of the first test to assess risk of developing acute
kidney injury |
| September 04, 2014 - U.S.
Marshals seize drug products from Flawless Beauty |
|
September 04, 2014 - FDA
approves Keytruda for advanced melanoma
|
| English |
| August 25, 2014 - FDA
takes action against Georgia dietary supplement manufacturer |
| August 20, 2014 - FDA
allows marketing of first ZnT8Ab autoantibody test to help diagnose
type 1 diabetes |
| August 19, 2014 - FDA
approves new drug to treat a form of Gaucher disease |
| August 15, 2014 - Turkish
man pleads guilty to importing illegal cancer drugs |
| August 14, 2014 - FDA
approves Avastin to treat patients with aggressive and late-stage
cervical cancer |
| August 14, 2014 - FDA
warns consumers about fraudulent Ebola treatment products |
| August 13, 2014 - FDA
approves new type of sleep drug, Belsomra |
| August 12, 2014 - FDA
approves donor lung preservation device that may result in more lung
transplants |
| August 11, 2014 - FDA
seeks permanent injunction against Michigan cheese manufacturer |
August 11, 2014 - FDA
approves first non-invasive DNA screening test for colorectal cancer
|
| August 06, 2014 - FDA
approves Orbactiv to treat skin infections |
|
August 01, 2014 - FDA
expands approval of drug to treat Pompe disease to patients of all
ages; removes risk mitigation strategy requirements
|
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August 01, 2014 - FDA
approves Jardiance to treat type 2 diabetes
|
| English |
| July 31, 2014 - FDA
approves Striverdi Respimat to treat chronic obstructive pulmonary
disease |
| July 31, 2014 - FDA
takes steps to help ensure the reliability of certain diagnostic tests |
| July 17, 2014 - FDA
approves new product to treat rare genetic disease |
| July 16, 2014 - Update
on findings in the FDA cold storage area on the NIH campus |
| July 09, 2014 - United
States enters consent decree with New York dietary supplement manufacturer |
|
July 03, 2014 - FDA
approves Beleodaq to treat rare, aggressive form of non-Hodgkin
lymphoma
|
| July 02, 2014 - Federal
judge approves consent decree with New York dietary supplement maker |
| July 01, 2014 - FDA
seeks permanent injunction against California pharmaceutical company |
|
July 01, 2014 - FDA
outlines expectations for human drug compounders, including registered
outsourcing facilities
|
| English |
other |
| June 27, 2014 - FDA
approves Afrezza to treat diabetes |
June 27, 2014 - La
FDA aprueba el Afrezza para tratar la diabetes |
| June 26, 2014 - FDA
allows marketing of first wearable, motorized device that helps people
with certain spinal cord injuries to walk |
June 26, 2014 - La
FDA permite la comercialización del primer dispositivo motorizado
para usarse puesto en el cuerpo y que ayuda a las personas con ciertas
lesiones de la médula espinal a caminar |
| June 26, 2014 - Kentucky
oncology practice and its manager plead guilty to purchasing and selling
unapproved chemotherapy drugs |
|
| June 24, 2014 - FDA
issues guidance to support the responsible development of nanotechnology
products |
|
| June 23, 2014 - Producer
of tainted dietary supplements sentenced in federal court |
|
| June 20, 2014 - FDA
approves Sivextro to treat skin infections |
|
| June 13, 2014 - FDA
approves Lymphoseek to help determine the extent of head and neck
cancer in the body |
|
| June 10, 2014 - FDA
and EPA issue draft updated advice for fish consumption |
June 10, 2014 - La
FDA y la EPA emiten aviso propuesto actualizado sobre el consumo de
pescado |
|
June 06, 2014 - FDA
approves the first antihemophilic factor, Fc fusion protein for
patients with Hemophilia A
|
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| June 02, 2014 - FDA
launches openFDA to provide easy access to valuable FDA public data |
June 02, 2014 - La
FDA pone en marcha openFDA para ofrecer un fácil acceso a
la valiosa información pública
|
| English |
other |
May 30, 2014 - FDA
approves first generic versions of celecoxib
|
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| May 29, 2014 - FDA
allows marketing of first non-invasive test to help in identifying
cause of certain kidney disease |
|
| May 29, 2014 - FDA
to require warnings on sunlamp products |
May 29, 2014 - La
FDA exigirá incluir advertencias en las lámparas para
bronceado |
| May 28, 2014 - FDA
approves first implantable wireless device with remote monitoring
to measure pulmonary artery pressure in certain heart failure patients |
May 28, 2014 - La
FDA aprueba el primer dispositivo inalámbrico implantable para
medir la presión arterial pulmonar a distancia en ciertos pacientes
con insuficiencia cardiaca |
May 23, 2014 - FDA
approves Dalvance to treat skin infections
|
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| May 22, 2014 - FDA
targets illegal online pharmacies in globally coordinated action |
May 22, 2014 - La
FDA arremete contra las farmacias virtuales ilícitas, en una
intervención coordinada a escala internacional |
| May 21, 2014 - FDA
approves first molecular (gene-based) test to determine red blood
cell types in transfusion medicine |
|
| May 20, 2014 - FDA
approves Entyvio to treat ulcerative colitis and Crohn's disease |
|
| May 16, 2014 - U.S.
Marshals seize unapproved drugs from Ohio distributor |
|
| May 15, 2014 - FDA
requiring lower starting dose for sleep drug Lunesta |
May 15, 2014 - La
FDA exige una dosis inicial menor para el medicamento para dormir
Lunesta |
| May 09, 2014 - FDA
allows marketing of first prosthetic arm that translates signals from
person’s muscles to perform complex tasks |
|
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May 08, 2014 - FDA
approves Zontivity to reduce the risk of heart attacks and stroke
in high-risk patients
|
May 08, 2014 - La
FDA aprueba el Zontivity para reducir el peligro de que los pacientes
de alto riesgo sufran infartos y derrames cerebrales
|
| English |
other |
| April 29, 2014 - United
States enters consent decree with New York cheese producer due to
Listeria contamination |
|
| April 29, 2014 - FDA
approves Zykadia for late-stage lung cancer |
|
| April 29, 2014 - FDA
issues proposals to address risks associated with surgical mesh for
transvaginal repair of pelvic organ prolapse |
|
| April 24, 2014 - FDA
approves first human papillomavirus test for primary cervical cancer
screening |
April 24, 2014 - La
FDA aprueba la primera prueba de virus del papiloma humano (VPH) para
la detección del cáncer cervical primario |
| April 24, 2014 -
FDA proposes to extend its tobacco authority to additional tobacco
products, including e-cigarettes |
April 24, 2014 - La
FDA propone ampliar su autoridad para regular otros productos de tabaco,
incluyendo los cigarros electrónicos |
| April 23, 2014 - FDA
approves Sylvant for rare Castleman's disease |
|
| April 22, 2014 - FDA
proposes new expedited access program for medical devices that address
unmet medical needs |
|
| April 21, 2014 - FDA
approves Cyramza for stomach cancer |
|
April 17, 2014 - FDA
approves Ragwitek for short ragweed pollen allergies
|
|
| April 17, 2014 - FDA
discourages use of laparoscopic power morcellation for removal of
uterus or uterine fibroids |
|
| April 16, 2014 - Puerto
Rico bakery agrees to stop manufacturing and distributing products |
April 16, 2014 - Panadería
de Puerto Rico se compromete a dejar de elaborar y distribuir sus
productos |
| April 15, 2014 - FDA
approves Tanzeum to treat type 2 diabetes |
April 15, 2014 - La
FDA aprueba el Tanzeum para tratar la diabetes tipo 2 |
| April 10, 2014 - FDA
approves expanded indication for certain pacemakers and defibrillators |
April 10, 2014 - La
FDA aprueba la ampliación de las indicaciones de uso de ciertos
marcapasos y desfibriladores para el tratamiento de la insuficiencia
cardiaca |
| April 07, 2014 - FDA
warns consumers not to use Zi Xiu Tang Bee Pollen capsules |
April 07, 2014 - La
FDA advierte a los consumidores no tomar la cápsulas de Polen
de Abeja Zi Xiu Tang
Read in Chinese
Read in Korean
Read in Japanese
|
| April 03, 2014 - FDA
allows marketing for first-of-kind dressing to control bleeding from
certain battlefield wounds |
April 03, 2014 - La
FDA aprueba la comercialización del primer vendaje de su clase
para el control del sangrado de ciertas heridas de batalla |
| April 03, 2014 - Proposed
health IT strategy aims to promote innovation, protect patients, and
avoid regulatory duplication |
|
| April 03, 2014 - FDA
Commissioner Margaret A. Hamburg Statement on Prescription Opioid
Abuse |
|
| April 03, 2014 - FDA
approves new hand-held auto-injector to reverse opioid overdose |
April 03, 2014 - La
FDA aprueba un nuevo inyector automático de bolsillo para revertir
las sobredosis de opiáceos |
| April 02, 2014 - FDA
approves first sublingual allergen extract for the treatment of certain
grass pollen allergies |
April 02, 2014 - La
FDA aprueba el primer extracto de alérgeno sublingual para
el tratamiento de algunos tipos de alergias al polen de las gramíneas |
| English |
other |
| March 28, 2014 - FDA
approves first long-acting recombinant coagulation Factor IX concentrate
for patients with Hemophilia B |
|
| March 28, 2014 - FDA
approves Topamax for migraine prevention in adolescents |
|
| March 28, 2014 - FDA
orders Wash.-based smoked seafood manufacturer to cease operations |
|
| March 21, 2014 - FDA
approves Otezla to treat psoriatic arthritis |
|
March 20, 2014 - FDA
approves first implantable hearing device for adults with a certain
kind of hearing loss
|
March 20, 2014 - La
FDA aprueba el primer dispositivo auditivo implantable para los adultos
con cierto tipo de pérdida de la audición |
| March 19, 2014 - FDA
approves Impavido to treat tropical disease leishmaniasis |
|
| March 17, 2014 - Some
lots of Simply Lite brand dark chocolate recalled |
|
| March 11, 2014 - FDA
allows marketing of first medical device to prevent migraine headaches |
March 11, 2014 - La
FDA autoriza la comercialización del primer dispositivo médico
para prevenir los dolores de cabeza de la migraña |
| English |
Other |
| February 27, 2014 - FDA
proposes updates to Nutrition Facts label on food packages |
February 27, 2014 - La
FDA propone actualizar la etiqueta de información nutricional
de los empaques de alimentos |
| February 25, 2014 - FDA
approves Myalept to treat rare metabolic disease |
|
| February 21, 2014 - FDA
issues first orders to stop sale, distribution of tobacco products |
February 21, 2014 - La
FDA da las primeras órdenes para parar la venta y distribución
de productos de tabaco |
| February 19, 2014 - FDA
and European Medicines Agency strengthen collaboration in pharmacovigilance
area |
|
| February 18, 2014 - FDA
approves Northera to treat neurogenic orthostatic hypotension |
|
| February 18, 2014 - FDA
initiates the Secure Supply Chain Pilot Program to enhance security
of imported drugs |
|
| February 14, 2014 - FDA
approves Vimizim to treat rare congenital enzyme disorder |
|
| February 13, 2014 - Illegal
prescription drug sellers arraigned on charges for smuggling illicit
cancer drugs into the United States |
|
| February 12, 2014 - FDA
approves Imbruvica to treat chronic lymphocytic leukemia |
|
| February 10, 2014 - FDA
warns against using Uncle Ben's Infused Rice |
February 10, 2014 - La
FDA advierte contra el consumo de arroz de sabores (Infused Rice)
de la marca Uncle Ben’s |
| February 06, 2014 - Updated
FDA requirements for infant formula will maintain high-quality standards
and help ensure healthy growth of infants |
February 06, 2014 - Los
requisitos actualizados de la FDA para la leche de fórmula
mantendrán las mismas altas normas de calidad y ayudarán
a asegurar que los bebés crezcan sanos |
| February 05, 2014 - FDA
Commissioner Hamburg travels to India |
|
| February 04, 2014 - FDA
launches its first national public education campaign to prevent,
reduce youth tobacco use |
February 04, 2014 - La
FDA lanza su primera campaña nacional de educación para
prevenir y reducir el consumo de tabaco entre la juventud |
| February 03, 2014 - FDA
approves pediatric use of Dexcom's G4 Platinum continuous glucose
monitoring system |
|
| English |
other |
| January 31, 2014 - FDA
Approves Hetlioz: first treatment for non-24 hour sleep-wake disorder
in blind individuals |
|
| January 31, 2014 - FDA
proposes rule to prevent food safety risks during transportation |
January 31, 2014 - Spanish - La
FDA propone un reglamento para evitar los riesgos a la seguridad de
los alimentos durante su transporte
January 31, 2014 - French - La
FDA propose une loi pour prévenir les risques en matière
de sécurité alimentaire pendant le transport des denrées.
January 31, 2014 - Read
in Chinese
January 31, 2014 - Read
in Arabic
January 31, 2014 - Read
in Russian
|
| January 28, 2014 - FDA
Statement on Western Sugar Cooperative voluntary recall of beet pulp
and tailings |
|
| January 23, 2014 - FDA
prohibits Ranbaxy's Toansa, India facility from producing and distributing
drugs for the U.S. market |
|
| January 22, 2014 - FDA
launches advisory committee membership nomination portal |
|
| January 17, 2014 - FDA
warns consumers not to eat oysters from Copano Bay in Aransas County,
Texas |
|
| January 17, 2014 - FDA
Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor's
Statement on the Institute of Medicine Report on Caffeine in Food
and Dietary Supplements |
|
| January 17, 2014 - FDA
allows marketing for first of-its-kind post-natal test to help diagnose
developmental delays and intellectual disabilities in children |
|
| January 17, 2014 - FDA
Commissioner Margaret A. Hamburg's Statement on the 50th Anniversary
Surgeon General's Report on Smoking and Health |
|
| January 10, 2014 - FDA
approves Mekinist in combination with Tafinlar for advanced melanoma |
January 10, 2014 - La
FDA aprueba el uso del Mekinist en combinación con el Tafinlar
para tratar etapas avanzadas de melanoma |
January 09, 2014 - FDA
approves first gel for sealing corneal incision after cataract surgery
|
|
January 08, 2014 - FDA
approves Farxiga to treat type 2 diabetes
|
January 08, 2014 - La
FDA aprueba el Farxiga para tratar la diabetes tipo 2 |
See the current
MedSun newsletter at the FDA website.
|
December
2014 MedSun Newsletter, includes:
- Gel-E Donut and Squishon 2 Products by Children’s Medical
Ventures: Recall
- FDA Infusion Pumps Website - Updated
- Laparoscopic Power Morcellation in Hysterectomy and Myomectomy:
FDA Safety Communication
- Respironics California, Esprit V1000 and V200 Ventilators: Class
I Recall
Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall
- Highlighted MedSun Reports
- Discussions with Healthcare Providers
|
|
November
2014 MedSun Newsletter, includes:
- Medi-Trace Cadence and Kendall Multi-function Defibrillation
Electrodes by Covidien: Field Safety Alert
- LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall
- CU Medical ConMed Stat2 Flow Controller: Class I Recall
- CareFusion EnVe and ReVel Ventilators: Class I Recall
- Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex
Medical: Class I Recall
- Highlighted MedSun Reports
|
| 08/28/14 DePuy
Synthes Craniomaxillofacial Distraction System: Class I Recall - May
Reverse Directions After Surgery |
| 08/14/14 CloverSnare
4-Loop Vascular Retrieval Snare by Cook Medical: Class I Recall |
| 08/26/14 Sterile
Convenience Surgical Packs by Customed, Inc.: Class I Recall |
| 08/19/14 Diamondback
360 Peripheral Orbital Atherectomy System by Cardiovascular Systems:
Class I Recall |
| 07/26/14 The
TJX Companies, Inc. Recalls "Ecoato" Sweet Paprika Powder
Due to Possible Health Risk |
| 07/25/14 GOMACRO
RECALLS "Almond Butter + Carob" and “Sunflower Butter
+ Chocolate” MacroBars Because of Possible Health Risk Carob
Powder Supplier May Have Exposed Ingredient to Salmonella |
| 07/21/2014 American
Health Packaging Announces the Voluntary Nationwide Recall of Ibuprofen
Tablets, USP, 600 mg, 100 Hospital Unit Dose and Oxcarbazepine Tablets,
300 mg, 100 Hospital Unit Dose |
| 07/20/2014 Wegmans
Issues Voluntary Recall of Bakery Products That May Contain Fresh
Peaches, Nectarines and Plums Supplied by Wawona Packing Company |
| 07/20/2014 Wawona
Packing Co. Takes Precautionary Step of Voluntarily Recalling Fresh,
Whole Peaches, Plums, Nectarines, and Pluots Because of Possible Health
Risk |
| 07/19/2014 Whole
Foods Market Hyannis Recalls Chocolate Chewies Cookies Due to Undeclared
Tree Nut Allergen |
| 07/18/2014 Unique
Pharmaceuticals, Ltd. Announces a Voluntary Nationwide Recall of all
Sterile Compounded Preparations Within Their Expiry Period Due to
a Lack of Sterility Assurance |
| 06/23/2014 Big
Sky Diagnostic Imaging, LLC: FDA Safety Communication |
| 06/20/2014 ConvaTec,
Inc., Flexi-Seal CONTROL Fecal Management System Kit: Class I Recall |
| 06/20/2014 HydroFinity
Hydrophilic Guidewires by NDC/Covidien: Recall |
| 06/13/2014 Smiths
Medical Portex Low Dead Space Connector with Sideport, 3.5mm: Class
I Recall |
|
06/11/2014 Advocate
Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast:
Recall
|
| 06/16/2014 Smith's
Country Cheese, Inc. Voluntarily RECALLS Waxed Gouda Wheels BECAUSE
OF POSSIBLE HEALTH RISK |
| 06/15/2014 Schnucks
Bakery Recalls Devil’s Food Cakes Topped With Undeclared Pecans |
| 05/28/2014 Navitas
Naturals Issues Voluntary Recall for Organic Sprouted Chia Seed Powder
Products |
| 05/28/2014 Eugene
Oregon, Inc. Issues Voluntary Nationwide Expansion Of The Recall Of
All Lots Of African Black Ant, Black Ant, And Mojo Risen Dietary Supplements
Which May Contain Undeclared Active Pharmaceutical Ingredients |
| 05/28/2014 Medical
Device Safety and Recalls: Fresenius NaturaLyte Liquid Bicarbonate
Concentrate (Part Number: 08-4000-LB) |
| 05/28/2014 Rome
Packing Co., Inc. Recalls Minced Crab Meat Because Of Possible Health
Risk |
| 05/28/2014 Pet
Center, Inc. Voluntary Recall of 3 oz bag of Lamb Crunchy’s Because
of Possible Health Risk |
| 05/23/2014 Brunkow
Cheese Issues Allergy Alert On Undeclared Soy In Jalapeno Pepper Raw
Milk Cheddar Cold Pack Cheese |
| 05/23/2014 Sun
Tree LLC Recalls 12oz Packaged California Grown Shelled Walnuts Due
to Possible Health Risk |
| 04/28/14 - Stonyfield
Announces Voluntary Recall of 188 6-packs of Yobaby Peach/Pear Yogurt
Cups from 40 Target Stores in the Southeast and 82 Mid-Atlantic Walmart
Stores |
| 02/09/14 - Trufill
n-BCA Liquid Embolic System by Codman Neuro: Recall FDA MedWatch
Safety Alert Codman Neuro is informing physicians of this incorrect
statement and updating the product's Instructions For Use (IFU). |
| 02/09/14 - t:slim
Insulin Cartridges by Tandem Diabetes Care: Recall FDA MedWatch
Safety Alert Tandem Diabetes Care announced that it is initiating
a voluntary recall of specific lots of insulin cartridges that are
used with the t:slim Insulin Pump. |
|
02/09/14 - Truebalance
and Truetrack Blood Glucose Meters by Nipro Diagnostics: Recall
FDA MedWatch Safety Alert The company determined that certain isolated
TRUEbalance and TRUEtrack Blood Glucose Meters have an incorrect
factory-set unit of measure that displays the glucose result in
mmol/L rather than mg/dl.
|
| 01/17/2014 - Stemvida
International StemAlive 90 Capsules Undeclared milk Stemvida International
Corporation Select to View Firm Press Release Select to View Image
of Product Label |
| 01/17/2014 - Crunch'N
Nutter Crunch'N Nutter Mixed Nut Undeclared Peanuts Merrell Food
Group Select to View Firm Press Release Select to View Image of Product
Label |
| 01/17/2014 - Rise'N
Roll Bakery and Deli and Rise'N Role Specialty All Varieties of Donuts,
Cinnamon Donut Holes, and Mixed Nut Candy Undeclared Eggs and Peanuts
Rise'N Roll Bakery Select to View Firm Press Release Select to View
Image of Product Label |
| 01/16/2014 - Rohto®
Eye drops Manufacturing review at the production facility in Vietnam
involving sterility controls The Mentholatum Company Select to View
Firm Press Release |
| 01/14/2014 - Paskesz
Chocolate Coins Undeclared milk Paskesz Candy Company Select to
View Firm Press Release Select to View Image of Product Label |
| 01/13/2014 - Pro
ArthMax Dietary Supplement Undeclared Ingredients Human Science
Foundation Select to View Firm Press Release Select to View Image
of Product Label |
| 01/10/2014 - t:slim®
Insulin Cartridges Cartridges may be at risk for leaking Tandem
Diabetes Care, Inc. Select to View Firm Press Release |
| 01/09/2014 - Boost
Ultra, XZone Gold & more Dietary Supplement for sexual enhancement
Unapproved new drug Midwest Wholesale Select to View Firm Press Release
Select to View Image of Product Label |
| 01/08/2014 - Kinnikinnick
Waffles, Mix, Bread Crumbs Undeclared milk Kinnikinnick Foods
Select to View Firm Press Release Select to View Image of Product
Label |
| 01/07/2014 - Marlyce
Butterballs cooked in soup Undeclared milk, whey, soy and wheat
L.M. Noodle Company, LLC |
| 01/03/2014 - Baxter
Clinimix CLINIMIX and CLINIMIX E Injection parenteral nutrition products
Particulate matter Baxter International Inc. Select to View Firm Press
Release Select to View Image of Product Label |
| 01/03/2014 -Tonia’s
Biscotti Lemon Biscotti Dipped in White Chocolate Undeclared milk,
soy and wheat Tonia’s Biscotti II LLC Select to View Firm Press
Release Select to View Image of Product Label |
| 01/02/2014 - Burn
7 Dietary Supplement Unapproved new drug Deseo Rebajar Inc. Select
to View Firm Press Release |
| 01/02/2014 - Moore/TRUEbalance
and Moore/TRUEtrack Blood Glucose Meters Incorrect factory-set
unit of measure that displays the glucose result in mmol/L rather
than mg/dL Nipro Diagnostics, Inc. |
|
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