VOLUNTA

Información principal

  • Denominación comercial:
  • VOLUNTA 10 mg COMPRIMIDOS RECUBIERTOS
  • Dosis:
  • 10 mg
  • formulario farmacéutico:
  • COMPRIMIDO RECUBIERTO
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático
  • Fabricado por:
  • SANOFI -AVENTIS DE COLOMBIA, S.A.

Documentos

Localización

  • Disponible en:
  • VOLUNTA 10 mg COMPRIMIDOS RECUBIERTOS
    Venezuela
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • Instituto Nacional de Higiene - República Bolivariana de Venezuela
  • Estado de Autorización:
  • VIGENTE
  • Número de autorización:
  • E.F.40.176
  • Fecha de autorización:
  • 16-09-2013
  • última actualización:
  • 03-09-2018

Prospecto

Gobiemo

Bolivariano

I

Ministerio

Poder Popular

de

Venezuela

para

salud

RCEF-R-0570/2013

Caracas,

de Septiembre de 2013

Ciudadano(a)

DR. (A). LEONARDO RAFAEL CADET VARGAS.

Farmaceutico Patrocinante

MEDLEY FARMACEUTICA, S.A.

Presente.-

De conformidad con

Oficio

RCEF-R-0569/2013

de fecha

16/09/2013

mediante

cual se le notific6

aprobaci6n del Producto Farmaceutico

VOLUNTA 10 mg COMPRIMIDOS RECUBIERTOS

W

Registro Sanitaria

E.F.40.176/13,

segun

consta

libro

EF-2013-01,

Pag.

286

usted

debera

cumplir

las siguientes condiciones de comercializaci6n:

COMUNICAR

A

LOS

PRESCRIPTORES

SEGUN

LO

ESTABLECIDO

EN

LA

LEY

DE

MEDICAMENTOS ARTiCULO 35,

siguiente:

lndicaciones:

Hipolipemiante

nilios mayores de

alios y adultos con

hipercolesterolemia prim aria,

hiperlipidemia

combinada

(mixta)

e hipercolesterolemia familiar heterocigota y homocigota,

cuando

respuesta a

dieta y a otras medidas

farmacol6gicas es inadecuada.

Prevenci6n de eventos isquemicos recurrentes

pacientes con dislipidemias y enfermedad

coronaria.

Posologia:

Como Hipolipemiante

pacientes con hipercolesterolemia primaria, hiperlipidemia combinada

(mixta) e hipercolesterolemia familiar heterocigota y homocigota, cuando

respuesta a

dieta

y a otras medidas no farmacol6gicas es inadecuada:

Nilios mayores de 10 alios: 10-20 mg/dfa. Dosis Maxima: 20 mg/dfa.

Adultos:

a 80 mg/dfa, ajustando dosis segun repuesta clfnica.

Prevenci6n de eventos isquemicos recurrentes

pacientes con dislipidemias y enfermedad

coronaria: 80 mg/dfa.

Advertencias:

caso de ser imprescindible

uso por

existir otra alternativa terapeutica, suspendase

lactancia mientras dure

tratamiento.

Este

producto

debe

administrarse

pacientes

intolerancia

Lactosa

o a

Galactosa.

Precauciones:

administraci6n

de este

producto

observado

alteraciones del

funcionalismo

hepatica,

por lo

que deben

realizarse

controles

de transaminasas,

creatinina fosfokinasa,

bilirrubina total y fraccionada durante

tratamiento.

Atorvastatina aumenta los niveles de digoxina

plasma, por lo tanto se debe ajustar

dosis de digoxina.

Contraindicaciones:

Hipersensibilidad a los componentes de

formula.

Pacientes

con disfunci6n o insuficiencia hepatica.

Ciudad Universitaria UCV, Los Chaguaramos. Caracas- Republica Bolivariana de Venezuela Cod.

1041

Telefono: (0058-0212) 219.1622- http://www.inhrr.gob.ve- RIF: G-20000101-1

E.F.40.176/13

F-PERC-007

Diciembre

2011

Revision 2

Pagina 1 de 3

Gobiemo

Bolivariano

I

Ministerio

Poder

Popular

Venezuela

para

salud

Nilios men ores de 1

0 alios.

Nose

administre durante el embarazo o cuando se sospeche su existencia.

Reacciones

Adversas:

Gastrointestinal: Dolor abdominal, flatulencia, constipacion, aumento de los perfiles hepaticas

(CPK, transaminasas, bilirrubina total y fraccionada), Pancreatitis.

Sistema nervioso central: Cefalea, mareo.

Sistema Genitourinario: lnsuficiencia Renal.

Musculoesqueletico: Mialgia, Rabdomiolisis.

Otros: Exantema.

lnteracciones:

Digoxina, antiacidos, eritromicina y anticonceptivos orales.

Se le asigna

producto un periodo de validez tentative de dos (02) alios, almacenado bajo las

condiciones climaticas de Venezuela (30

± 2

170%

HR), en el envase BLISTER

PVC-PVDC TRANSPARENTE E INCOLORO

I

FOIL

ALUMINIO, con el compromise de remitir

resultados analiticos de estabilidad para los tres (03) primeros lotes comerciales, cada tres (03)

meses durante

primer alio y cada seis (06) meses durante el segundo alio del periodo de

validez asignado.

Debe remitir con

notificacion del inicio de

comercializacion del primer lote del producto,

Certificado Analitico de

Materia Prima correspondiente al primer lote comercial, incluyendo

nombre y firma del profesional responsable de los resultados analiticos reportados.

Remitir una vez que el mismo se encuentre disponible,

Certificado de Buenas Practicas de

Manufactura original y vigente o en su defecto

copia compulsada del mismo.

El texto de empaque se considera NO CONFORME, debe contener

siguiente informacion:

lndicacion

Posologia:

A juicio del Facultative.

Administracion:

Oral.

Adverten

cias:

Producto de uso delicado que debe ser administrado bajo vigilancia medica.

caso de ser imprescindible su uso por

existir otra alternativa terapeutica, suspendase

lactancia mientras dure el tratamiento.

Este producto

debe administrarse en pacientes con intolerancia a

Lactosa o a

Galactosa.

Mantengase fuera del alcance de los nilios.

No exceda

dosis prescrita.

Antes de administrar este producto, leer el prospecto interne.

Contraindicaciones:

Alergia a los componentes de

formula.

No se administre durante el embarazo o cuando se sospeche su existencia.

Prescripci6n

Facultativa.

Corregir texto de empaque y prospecto interne segun modelos anexos, y agregar las condiciones

y restricciones de uso contenidas en el presente Oficio.

caso

requerir variacion

presentaciones aprobadas,

debera

realizar

tramite

individual correspondiente

Remitir periodicamente, Certificado de Producto Farmaceutico, Certificado de Libre Venta y/o

Certificado de Buenas Practicas de Manufactura, vigentes.

Ciudad Universitaria UCV, Los Chaguaramos. Caracas- Republica Bolivariana de Venezuela Cod.

1041

Telefono: (0058-0212) 219.1622- http://www.inhrr.gob.ve- RIF: G-200001

01-1

E.F.40.176/13

F-PERC-007

Diciembre

2011

Revision 2

Pagina 2 de 3

Gobiemo

Bolivariano

I

Ministerio

Poder

Popular

Venezuela

para

satud

textos de empaque, etiqueta, unidad posol6gica y prospecto interno deben adecuarse,

segun

caso,

establecido

Oficio

Aprobaci6n,

Oficio

Condiciones

Comercializaci6n, las Normas y Boletines de

Junta Revisora de Productos Farmaceuticos.

Comunicar

lnstituto Nacional de Higiene "Rafael Rangel", a traves del Centro Nacional

Farmacovigilancia (CENAVIF), cualquier efecto

descrito durante

proceso

evaluaci6n

Registro Sanitaria que derive de

actividad farmacol6gica del

mismo o de alguno

ingredientes y del cual se tenga conocimiento despues de aprobado

producto.

Presentar ante

lnstituto Nacional de Higiene "Rafael Rangel", cualquier cambia que tenga

producto durante

periodo de Comercializaci6n, relacionado

aspectos

textos, legales,

farmaceuticos y clfnicos, para

cual debera emplear los formularies de solicitud

cambia

post-

registro vigentes y/o comunicaciones.

Debe

indicar

Despacho

cuatro

(04)

meses

anticipaci6n,

fecha

probable

comercializaci6n

producto

farmaceutico.

este

lapso

tiempo

procedera

EVALUACION de

metodologia analitica utilizada

control de calidad del producto y a

programaci6n respectiva.

fines del estricto cumplimiento del Articulo 60 del Reglamento de

Ley del Ejercicio

Farmacia vigente, publicado

Gaceta Oficial

4.582 extraordinario de fecha

Mayo

1993,

informa

estan

obligados

participar

lnstituto

Nacional

Higiene

"Rafael Rangel"

fecha

cual se inicie

comercializaci6n del primer late elaborado,

manera que los funcionarios acreditados del

lnstituto Nacional de

Higiene "Rafael

Rangel",

puedan proceder a captar las muestras correspondientes

propio sitio de fabricaci6n, o

distribuci6n

caso de los productos importados.

lgualmente se

informa que dispone de quince

(15)

dias habiles, para solicitar a esta GERENCIA,

reconsideraci6n de las exigencias serialadas ANTERIORMENTE. Transcurrido dicho lapso queda

usted

obligaci6n de cumplir

las condiciones de usa bajo

las cuales fue aprobado

producto.

incumplimiento

alguna

condiciones

comercializaci6n

sera

sancionado

CANCELACION del producto.

Mrf£,£tl/MNQ.-

Ciu~~~niversitaria

UCV,

Chaguaramos. Caracas - Republica Bolivariana de Venezuela

Cod.

Telefono: (0058-0212) 219.1622- http://www.inhrr.gob.ve-

RIF:

G-20000101-1

E.F.40.176/13

F-PERC-007

Diciembre 2011

Revisi6n 2

Pagina 3 de 3

19-11-2018

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

One lot each of Option Family Sunscreen Lotion SPF 50 and Personnelle Sport Sunscreen Lotion SPF 50 have been voluntarily recalled by Empack Spraytech Inc. because of bacterial contamination.

Health Canada

17-11-2018

The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap’n Crunch’s Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk

The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap’n Crunch’s Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk

The Quaker Oats Company, a subsidiary of PepsiCo, Inc., today announced a voluntary recall of a small quantity of Cap’n Crunch’s Peanut Butter Crunch cereal due to the potential presence of Salmonella. While the potentially affected product only reached five specific Target stores and is limited to 21 boxes of one variety with two Best Before Dates, Quaker is initiating the voluntary recall to protect public health.

FDA - U.S. Food and Drug Administration

14-11-2018

Several children's strawberry-flavoured acetaminophen syrups recalled because of defective child-resistant safety caps on the bottles

Several children's strawberry-flavoured acetaminophen syrups recalled because of defective child-resistant safety caps on the bottles

Laboratoire RivaInc. and Laboratoires Trianon Inc. are voluntarily recalling several over-the-counter children’s strawberry-flavoured acetaminophen syrups labeled as Biomedic, Option, or Laboratoires Trianon Inc. The products, which are used for pain and fever relief, are being recalled because the child-resistant safety cap may be defective.

Health Canada

13-11-2018

Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

On September 26, 2018 Oscor notified customers of a recall for certain lots (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As part of the recall correction activities, Oscor is retrieving any remaining inventory out in the field. The recall scope is being expanded to include expired inventory for devices distributed between December 21, 2011 to May 17, 2018. The recall expansion is to ensure proper disposition of expired units. The FDA has been notified and is aware Oscor In...

FDA - U.S. Food and Drug Administration

13-11-2018

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

ALEBRIJE DIST WHOLESALE is collaborating with health officials due to a positive finding of Salmonella in a sample of Quesillo “Queseria La Milagrosa”. ALEBRIJE DIST WHOLESALE is voluntarily recalling the amount of 100 kilos of Quesillo “Queseria La Milagrosa”. While “Alebrije Cheese” has not been found positive for Salmonella, ALEBRIJE DIST WHOLESALE has decided to voluntarily recall the specific 498 “Alebrije Cheese” pieces that were imported during the same period out of an abundance of caution.

FDA - U.S. Food and Drug Administration

9-11-2018

In Association With Sunshine Mills, Lidl Voluntarily Recalls Orlando Brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food Due to Elevated Levels of Vitamin D.

In Association With Sunshine Mills, Lidl Voluntarily Recalls Orlando Brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food Due to Elevated Levels of Vitamin D.

In association with Sunshine Mills, Lidl is voluntarily recalling specific lots of Orlando brand Grain Free Chicken & Chickpea Superfood Recipe Dog Food because the products may contain elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

9-11-2018

Baked Potatoes with Cheddar Cheese and Bacon (2 Count) Mis-Labeled as Herb Roasted Potatoes

Baked Potatoes with Cheddar Cheese and Bacon (2 Count) Mis-Labeled as Herb Roasted Potatoes

Ukrop’s Homestyle Foods is voluntarily recalling Baked Potatoes with Cheddar Cheese and Bacon (2 count), as the product is mislabeled Herb Roasted Potatoes (see photo attached).

FDA - U.S. Food and Drug Administration

8-11-2018

Wegmans Food Markets, Inc. Issues Allergy Alert on Undeclared Milk in Wegmans Pumpkin Loaf, 11 oz., and Wegmans Placek Coffee Cake, 11 oz. and 22 oz.

Wegmans Food Markets, Inc. Issues Allergy Alert on Undeclared Milk in Wegmans Pumpkin Loaf, 11 oz., and Wegmans Placek Coffee Cake, 11 oz. and 22 oz.

Wegmans has initiated a voluntary recall of the following products because they may contain milk not declared on the label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

7-11-2018

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

FDA - U.S. Food and Drug Administration

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

6-11-2018

Duncan Hines Classic White, Classic Butter Golden, Signature Confetti and Classic Yellow Cake Mixes Recalled Due to Potential Presence of Salmonella

Duncan Hines Classic White, Classic Butter Golden, Signature Confetti and Classic Yellow Cake Mixes Recalled Due to Potential Presence of Salmonella

Conagra Brands is collaborating with health officials in connection with a positive finding of Salmonella in a retail sample of Duncan Hines Classic White cake mix that may be linked to a Salmonella outbreak that is currently being investigated by CDC and FDA. While it has not been definitively concluded that this product is linked to the outbreak and the investigation is still ongoing, Conagra has decided to voluntarily recall the specific Duncan Hines variety identified (Classic White) and three other ...

FDA - U.S. Food and Drug Administration

3-11-2018

Nutrisca Issues Recall of Dry Dog Food Due to Elevated Levels of Vitamin D

Nutrisca Issues Recall of Dry Dog Food Due to Elevated Levels of Vitamin D

Nutrisca, of Saint Louis, Missouri is voluntarily recalling one formula of Nutrisca dry dog food (described below) due to it containing elevated levels of vitamin D.

FDA - U.S. Food and Drug Administration

3-11-2018

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products of Saint Louis, Missouri is voluntarily recalling our Chicken & Potato dry dog food (described below) due to it containing elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

3-11-2018

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

FDA - U.S. Food and Drug Administration

2-11-2018

Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Smartfood Delight Sea Salt Flavored Popcorn

Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Smartfood Delight Sea Salt Flavored Popcorn

Frito-Lay announced a voluntary recall of select 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn because they were inadvertently filled with cheese flavored tortilla chips that contain undeclared milk ingredients. The recalled bags were sold only in the two variety packs listed below.

FDA - U.S. Food and Drug Administration

1-11-2018

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing.

FDA - U.S. Food and Drug Administration

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

30-10-2018

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

J&J Snack Foods Handheld Corp. of Holly Ridge, NC is voluntarily recalling two lots of Fit & Active Southwest Veggie Stuffed Sandwiches due to potential contamination with Listeria monocytogenes and Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

FDA - U.S. Food and Drug Administration

29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

26-10-2018

Urgent: Curry Spice Recall

Urgent: Curry Spice Recall

This voluntary recall has been initiated by UBC Food Distributors Inc, due to a high level of lead found in the product after testing was done by the Michigan Department of Agriculture & Rural Development, which found high traces of lead.

FDA - U.S. Food and Drug Administration

22-10-2018

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials, to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.

FDA - U.S. Food and Drug Administration

19-10-2018

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. of St. Petersburg, FL is expanding its voluntary recall to include all ice cream manufactured from August 29, 2017 – October 11, 2018, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nause...

FDA - U.S. Food and Drug Administration

19-10-2018

Cedar’s Mediterranean Foods Issues Allergy Alert on Undeclared Soy in Cedar’s Chickpea Salad 8 oz.

Cedar’s Mediterranean Foods Issues Allergy Alert on Undeclared Soy in Cedar’s Chickpea Salad 8 oz.

Cedar’s Mediterranean Foods, of Ward Hill, MA is voluntarily recalling Cedar’s Chickpea Salad 8 oz. because it may contain undeclared edamame (soy). People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

19-10-2018

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling six of its meat and potato products across its eight-state region due to possible contamination with Salmonella and Listeria monocytogenes. The potential for contamination was discovered after Hy-Vee’s supplier, McCain Foods, announced it was recalling its caramelized mushrooms and fire-roasted tomatoes, which are ingredients that are used in six Hy-Vee products. To date, no illnesses have been reported in connection with these prod...

FDA - U.S. Food and Drug Administration

17-10-2018

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. of Faribault, MN is recalling its 15 ounce S&W White Beans because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

16-10-2018

Fat Burners Zone Issues Voluntary Nationwide Recall of Zero Xtreme Due to Presence of Undeclared Sibutramine

Fat Burners Zone Issues Voluntary Nationwide Recall of Zero Xtreme Due to Presence of Undeclared Sibutramine

Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme, capsules to the consumer level. FDA analysis has found Zero Xtreme to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. The presence of Sibutramine in Zero Xtreme renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

FDA - U.S. Food and Drug Administration

12-10-2018

Voluntary Recall of Limited Amounts of Nuts & Vanilla Protein Plant Shake

Voluntary Recall of Limited Amounts of Nuts & Vanilla Protein Plant Shake

Forager Project is recalling three dates of Nuts and Vanilla – Organic Plant Protein Shake because the product contains almond flour which is not declared on the label.

FDA - U.S. Food and Drug Administration

10-10-2018

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Liveyon marketed and distributed these products under the trade name ReGen Series®. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions.

FDA - U.S. Food and Drug Administration

10-10-2018

Voluntary Recall Issued for Sweet Me Creamery Brookie Dough Ice Cream that may Contain an Undeclared Peanut Allergen

Voluntary Recall Issued for Sweet Me Creamery Brookie Dough Ice Cream that may Contain an Undeclared Peanut Allergen

Kemps of St. Paul, Minn., is voluntarily recalling Sweet Me Creamery Brookie Dough ice cream, individual pints and pint four-packs, because it may contain an undeclared peanut allergen. Individuals who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.

FDA - U.S. Food and Drug Administration

6-10-2018

Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk

Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk

Ladyfingers Caterers is voluntarily recalling its Signature Shaved Country Ham Rolls as a result of the Johnston County Hams recall. The rolls were made with ham produced by Johnston County Hams, which recently initiated a recall of its ham products due to possible contamination with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer onl...

FDA - U.S. Food and Drug Administration

5-10-2018

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Johnston County Hams, Inc. issued a voluntary recall on October 3, 2018 for approximately 89,096 pounds of ready-to-eat ham products due to possible contamination with Listeria monocytogenes. In response, Callie's Charleston Biscuits, LLC is issuing a voluntary product recall for two products that may contain the potentially affected Johnston County Hams.

FDA - U.S. Food and Drug Administration

5-10-2018

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade Ice Cream, Inc. of St. Petersburg, FL is conducting a voluntary recall of No Sugar Added Vanilla and No Sugar Added Chocolate ice cream manufactured in three-gallon tubs during the month of May 2018. The recall is being conducted due to a potential contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only...

FDA - U.S. Food and Drug Administration

4-10-2018

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

FDA - U.S. Food and Drug Administration

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

27-9-2018

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

Mauna Loa Macadamia Nut Corporation is voluntarily recalling all of its products produced at the Keaau facility between Sept. 6 - 21, 2018 due to a potential contamination of Escherichia coli (E. coli). The recall was initiated due to E. coli being detected in the well water and distribution system that supplies the firm's operations. No illnesses related to the water have been reported to the state.

FDA - U.S. Food and Drug Administration

25-9-2018

Allergy Alert Issued in Whole Foods Market Stores Nationwide for Undeclared Milk in 365 Everyday Value White Corn Tortilla Chips

Allergy Alert Issued in Whole Foods Market Stores Nationwide for Undeclared Milk in 365 Everyday Value White Corn Tortilla Chips

Whole Foods Market is voluntarily recalling 365 Everyday Value White Corn Tortilla Chips because the product may contain undeclared milk that was not listed on the product label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product

FDA - U.S. Food and Drug Administration

25-9-2018

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

FDA - U.S. Food and Drug Administration

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

18-9-2018

Lidl Voluntarily Recalls Bellona Brand Hazelnut Wafers Due to Improperly Declared Wheat Allergen

Lidl Voluntarily Recalls Bellona Brand Hazelnut Wafers Due to Improperly Declared Wheat Allergen

Lidl US has voluntarily recalled all Bellona brand “Milk Chocolate Flavored Coated Wafer with Hazelnut Crème Filling and White Chocolate Flavor” confections as a precautionary measure because the allergen statement does not include wheat.

FDA - U.S. Food and Drug Administration

13-9-2018

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel to the retail and consumer level. King Bio Inc., a manufacturer of some of the active ingredients in this product, has been found to have some water contamination issues that potentially could have affected this product. King Bio has issued a recall of these active ingredients in BioLyte’s lot specific product. To date, there have been no reports of illness or...

FDA - U.S. Food and Drug Administration

12-9-2018

Voluntary Recall Notice of Meijer Taco Seasoning Mix 4.5 oz.

Voluntary Recall Notice of Meijer Taco Seasoning Mix 4.5 oz.

McCormick & Company, Inc. is initiating a voluntary recall of Meijer Taco Seasoning Mix 4.5 OZ bottle due to an unlabeled milk allergen

FDA - U.S. Food and Drug Administration

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

8-9-2018

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food of Salt Lake City, Utah is voluntarily recalling one lot of 5lb Turducken Recipe, one lot of 2lb Quest Emu Diet, and one lot of 2lb Quest Beef Diet, due to their possible Salmonella and/or L. mono contamination.

FDA - U.S. Food and Drug Administration

8-9-2018

Gravel Ridge Farms Recalls Cage Free Egg Due to Possible Salmonella Contamination

Gravel Ridge Farms Recalls Cage Free Egg Due to Possible Salmonella Contamination

Gravel Ridge Farms is recalling Cage Free Large Eggs due to a potential contamination of Salmonella. The recall was initiated because reported illnesses were confirmed at locations using Gravel Ridge Farm Eggs, and we are voluntarily recalling out of an abundance of caution.

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

6-9-2018

Beaumont Bio Med, Inc. Issues Voluntary Nationwide Recall of all their Homeopathic Aqueous/Alcohol-Based Medicines due to the Nationwide Recall by the Contract Manufacturer, King Bio, of all their Aqueous-Based Products due to Possible Microbial Contamina

Beaumont Bio Med, Inc. Issues Voluntary Nationwide Recall of all their Homeopathic Aqueous/Alcohol-Based Medicines due to the Nationwide Recall by the Contract Manufacturer, King Bio, of all their Aqueous-Based Products due to Possible Microbial Contamina

Beaumont Bio Med, Inc. is voluntarily recalling its entire aqueous/alcohol-based product line for human use, within expiry, to the consumer level. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

31-8-2018

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study. The US Food and Drug Administration (FD...

FDA - U.S. Food and Drug Administration

29-8-2018

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia. Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled...

FDA - U.S. Food and Drug Administration

29-8-2018

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

28-8-2018

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).

FDA - U.S. Food and Drug Administration

28-8-2018

Living Well Remedies, LLC Issues Voluntary Nationwide Recall of Weight Away Remedy, Lot # 111417LWL614, Due To Microbial Contamination

Living Well Remedies, LLC Issues Voluntary Nationwide Recall of Weight Away Remedy, Lot # 111417LWL614, Due To Microbial Contamination

Franklin Lakes, NJ, Living Well Remedies, LLC is voluntarily recalling Weight Away Remedy lot# 111417LWL614 to the consumer level. The independent manufacturing facility that produced this lot reported it to be out of specification for microbial testing.

FDA - U.S. Food and Drug Administration

28-8-2018

King Bio Issues Voluntary Nationwide Recall of All Aqueous-Based Products for Human and Animal Use Due to Possible Microbial Contamination

King Bio Issues Voluntary Nationwide Recall of All Aqueous-Based Products for Human and Animal Use Due to Possible Microbial Contamination

King Bio is voluntarily recalling all of its aqueous-based products for human and animal use (see website link below), within expiry, to the consumer level due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

22-8-2018

King Bio Issues Voluntary Nationwide Recall of It’s Kids and Infant Products Due to Potential Microbial Contamination

King Bio Issues Voluntary Nationwide Recall of It’s Kids and Infant Products Due to Potential Microbial Contamination

King Bio is voluntarily recalling the below products to the consumer level. A small percentage of our products produced between 08/01/2017 and 04/2018 have tested positive for microbial contamination. Out of an abundance of caution, we are recalling the products and lot numbers below

FDA - U.S. Food and Drug Administration

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

21-8-2018

Lipari Foods Issues Voluntary Recall of Premo Brand Turkey & Cheese Wedge Sandwiches Because of Possible Health Risk

Lipari Foods Issues Voluntary Recall of Premo Brand Turkey & Cheese Wedge Sandwiches Because of Possible Health Risk

Lipari Foods, LLC has issued a voluntary recall of Premo Brand turkey and cheese wedge sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

19-9-2018

Every disaster is different & each person has unique needs after #Florence. A variety of resources may be available to help with recovery:

Call 2-1-1 to connect with local sources of help.
 http://DisasterAssistance.gov  connects you with federal or volu

Every disaster is different & each person has unique needs after #Florence. A variety of resources may be available to help with recovery: Call 2-1-1 to connect with local sources of help. http://DisasterAssistance.gov  connects you with federal or volu

Every disaster is different & each person has unique needs after #Florence. A variety of resources may be available to help with recovery: Call 2-1-1 to connect with local sources of help. http://DisasterAssistance.gov  connects you with federal or voluntary organization resources. pic.twitter.com/UYuxr0yvF0

FDA - U.S. Food and Drug Administration