Gallimune SE + St Vaccine

Main information

  • Trade name:
  • Gallimune SE + St Vaccine
  • Pharmaceutical form:
  • Emulsion for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Gallimune SE + St Vaccine
    Slovenia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Salmonella vaccine
  • Therapeutic area:
  • Chicken Layers, Chicken Other

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0001/001
  • Authorization date:
  • 13-01-2012
  • EU code:
  • UK/V/0001/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:March2012

AN:00482/2011

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

GallimuneSe+St,water-inoilemulsionforinjection

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each0.3-mldoseofvaccinecontains:

Activesubstances:

InactivatedSalmonellaEnteritidisPT4,atleast..................................................171SAT.U

InactivatedSalmonellaTyphimuriumDT104,atleast........................................149SAT.U

Adjuvant:

Paraffinoil...................................................................................................................q.s.0.3ml

Excipient:

Thiomersal,atmost............................................................................................................30µg

Theconcentrationsareexpressedbytheantibodytitreobtainedduringthe

potencytest.Oneunit(U)correspondingtoanantibodytitreof1.

SAT:SlowAgglutinationTest.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Water-inoilemulsionforinjection.

Whiteemulsion.

4. CLINICALPARTICULARS

4.1 Targetspecies

Chickens(layerpullets).

4.2 Indicationsforuse,specifyingthetargetspecies

Foractiveimmunisationoflayerpulletsto:

- reduceSalmonellaEnteritidisdisseminationintheovary,asdemonstrated

4daysafterchallenge;

Thishasbeentested25weeksaftervaccinationandhasbeendemonstrated

topersistuntil58weeksofage.

-reduceSalmonellaTyphimuriumandSalmonellaEnteritidisdissemination

intheintestinaltract.

Revised:March2012

AN:00482/2011

Page2of5

Thishasbeentested4weeksaftervaccinationandhasbeendemonstrated

topersistuntil61weeksofageforSalmonellaTyphimuriumand52weeksof

ageforSalmonellaEnteritidis.

4.3 Contraindications

Pleaserefertosection4.7“Useduringpregnancy,lactationorlay”.

4.4 Specialwarnings

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Vaccinateonlyhealthyanimals.

Vaccinationcausesaserologicalresponseinchickenswhichmayinterfere

withasurveillanceprogrambasedsolelyonserologicalscreeningwithout

confirmatorybacteriology.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Totheuser:

Thisproductcontainsmineraloil.Accidentalinjection/selfinjectionmayresult

inseverepainandswelling,particularlyifinjectedintoajointorfinger,andin

rarecasescouldresultinthelossoftheaffectedfingerifpromptmedical

attentionisnotgiven.

Ifyouareaccidentallyinjectedwiththisproduct,seekpromptmedicaladvice

evenifonlyaverysmallamountisinjectedandtakethepackageleafletwith

you.

Ifpainpersistsformorethan12hoursaftermedicalexamination,seek

medicaladviceagain.

Tothephysician:

Thisproductcontainsmineraloil.Evenifsmallamountshavebeeninjected,

accidentalinjectionwiththisproductcancauseintenseswelling,whichmay,

forexample,resultinischaemicnecrosisandeventhelossofadigit.Expert,

PROMPT,surgicalattentionisrequiredandmaynecessitateearlyincision

andirrigationoftheinjectedarea,especiallywherethereisinvolvementof

fingerpulportendon.

4.6Adversereactions(frequencyandseriousness)

Nopalpablereactionswereobservedfollowingtheinjectionofonedoseof

vaccine.

Smalllesionslinkedtotheoilyadjuvant,e.g.smallquantitiesofoilyresidues,

wereobservedattheinjectionsitethreeweeksaftertheinjectionandmay

persistthroughlayanddeclineovertime.

Revised:March2012

AN:00482/2011

Page3of5

Aslightdelayintheonsetoflaymaybeobserved,howevernoimpacton

peakproductionoroveralleggproductivityhasbeenobserved.

4.7Useduringpregnancy,lactationorlay

Nottobeusedwithin2weeksbeforetheonsetofthelayingperiodorduring

thelayingperiod.

4.8Interactionwithothermedicinalproductsandotherformsof

interaction

Safetyandefficacydataareavailablewhichdemonstratethatthevaccinecan

beadministeredonthesamedaybutnotmixedwithinactivatedvaccinesfor

chickensofMerialGallimunerangeagainstEggDropSyndrome(EDS76),

NewcastleDisease,InfectiousBronchitis(Mass41)andAvianRhinotracheitis

(SwollenHeadSyndrome).

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhen

usedwithanyotherveterinarymedicinalproductexcepttheproducts

mentionedabove.Adecisiontousethisvaccinebeforeorafteranyother

veterinaryproductthereforeneedstobemadeonacasebycasebasis.

4.9 Amountstobeadministeredandadministrationroute

Injectbyintramuscularrouteonedose(0.3ml)ofvaccine,accordingtothe

followingvaccinationscheme:

- firstinjection:fromtheageof6weeks;

- secondinjection:attheageof16weeks.

Theintervalbetweenthetwoinjectionsshouldbeatleast4weeksandat

most10weeks.

Shakewellbeforeuse.

Applyusualasepticprocedures.

Donotusesyringeswithnaturalrubberorbutylelastomerpistons.

Equipmentincludingneedlesandsyringesmustbesterilebeforeuse.

4.10Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

Inadditiontothe effectsmentionedinparagraph“Adversereactions

frequencyandseriousness)”,inflammatoryreactionshavebeenobservedat

theinjectionsiteafteradministrationoftwicetherecommendeddoseof

vaccine.

4.11Withdrawalperiod(s)

Zerodays.

Revised:March2012

AN:00482/2011

Page4of5

5. IMMUNOLOGICALPROPERTIES

InactivatedvaccineinoilyadjuvantagainstSalmonellaEnteritidisand

SalmonellaTyphimurium.

ThevaccinestimulatesactiveimmunityoflayerpulletsagainstSalmonella

EnteritidisandSalmonellaTyphimurium.

TheSEstrainisclassifiedasphagotype4,theSTstrainisclassifiedas

DefinitiveTypeDT104.

Althoughthefollowinghasnotbeeninvestigated,thevaccinemaybe

expectedtoreduceSalmonellaEnteritidistransovarianeggcontaminationand

SalmonellaTyphimuriumandSalmonellaEnteritidiseggshellcontamination.

ATCvetcode:QI01AB01.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

- Thiomersal.

- Formaldehyde.

- Esteroffattyacidsandethoxylatedpolyols.

- Esteroffattyacidsandpolyols.

- Waterforinjections.

6.2Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:18months.

Shelf-lifeafterfirstopeningtheimmediatepackaging:useimmediatelyafter

opening.

6.4.Specialprecautionsforstorage

Storeandtransportrefrigeratedbetween+2

Cand+8

C,protectedfromlight.

Donotfreeze.

Keepthebottleintheoutercarton.

6.5Natureandcompositionofimmediatepackaging

Natureofprimarypackagingelements:

- Polypropylenebottle.

- Nitrileelastomerclosure.

- Aluminiumcap.

Salespresentations:

- 300-ml(1,000-dose)bottle.

- 300-ml(1,000-dose)bottle,boxof10bottles.

Revised:March2012

AN:00482/2011

Page5of5

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

MerialAnimalHealthLtd

POBox327

SandringhamHouse

HarlowBusinessPark

Harlow

Essex

CM195TG

8. MARKETINGAUTHORISATIONNUMBER

Vm08327/4222

9. DATEOFFIRSTAUTHORISATION

11June2007

10 DATEOFREVISIONOFTHETEXT

March2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Theimport,sale,supplyand/oruseofthismedicinalproductisormaybe

prohibitedincertainMemberStatesonthewholeorpartoftheirterritory

pursuanttonationalanimalhealthpolicy.Anypersonintendingtoimport,sell,

supplyand/orusethismedicinalproductmustconsulttherelevantMember

State’scompetentauthorityonthecurrentvaccinationpoliciespriortothe

import,sale,supplyand/oruse.

27-11-2018

Achdut Recalls Multiple Brands of "Tahini" Because It May Be Contaminated with Salmonella

Achdut Recalls Multiple Brands of "Tahini" Because It May Be Contaminated with Salmonella

Achdut LTD. of Ariel, Israel, is recalling its Tahini products of all packages and sizes produced on the following dates: April 7th to May 21st 2018, because it may be contaminated with Salmonella, an organism which 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

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

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

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

6-11-2018

FDA Investigating Recalled Duncan Hines Cake Mixes Potentially Linked to Salmonella Agbeni Illnesses

FDA Investigating Recalled Duncan Hines Cake Mixes Potentially Linked to Salmonella Agbeni Illnesses

The FDA is investigating the manufacturing facility that made recalled Duncan Hines cake mixes.

FDA - U.S. Food and Drug Administration

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

2-11-2018

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company of Baltimore, Maryland is recalling 239 cases of roasted and salted in shell pistachios, because it has the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

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

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

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

9-10-2018

Notice of call for expressions of interest - Salmonella molecular serotyping

Notice of call for expressions of interest - Salmonella molecular serotyping

France - Agence Nationale du Médicament Vétérinaire

20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Bravo Packing, Inc. Recalls Performance Dog Raw Pet Food Because of Possible Salmonella Health Risk to Humans and Animals

Bravo Packing, Inc. Recalls Performance Dog Raw Pet Food Because of Possible Salmonella Health Risk to Humans and Animals

Bravo Packing, Inc. of Carneys Point, NJ is recalling all Performance Dog products, a frozen raw pet food, because it has the potential to be contaminated with Salmonella. Salmonella can cause illness in animals eating the products, as well as people who handle contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products, infected animals or any surfaces exposed to these products.

FDA - U.S. Food and Drug Administration

10-9-2018

FDA Investigating Multistate Outbreak of Salmonella Enteritidis Linked to Shell Eggs from Gravel Ridge Farms

FDA Investigating Multistate Outbreak of Salmonella Enteritidis Linked to Shell Eggs from Gravel Ridge Farms

Outbreak of Salmonella Enteritidis Linked to Shell Eggs

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

16-8-2018

Zakah Life Recalls Kratom Because Of Possible Health Risk

Zakah Life Recalls Kratom Because Of Possible Health Risk

Zakah Life, LLC of Ankeny, Iowa, is recalling the following Kratom products (Super Green Maeng Da Premium Kratom powder, Powerful Red Vein Bali Premium Kratom powder, Super Green Maeng Da Premium Kratom capsules, and Powerful Red Vein Bali Premium Kratom capsules) with expiration dates prior to 01/01/2023 because they have the potential of being contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weak...

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

26-7-2018

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Multi country Salmonella Agona outbreak possibly linked to ready-to-eat food

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

24-7-2018

Pepperidge Farm® Announces Voluntary Recall of Four Varieties of Goldfish® Crackers

Pepperidge Farm® Announces Voluntary Recall of Four Varieties of Goldfish® Crackers

Pepperidge Farm has been notified by one of its ingredient suppliers that whey powder in a seasoning that is applied to four varieties of crackers has been the subject of a recall by the whey powder manufacturer due to the potential presence of Salmonella. Pepperidge Farm initiated an investigation and, out of an abundance of caution, is voluntarily recalling four varieties of Goldfish crackers. The products were distributed throughout the United States. No illnesses have been reported. ...

FDA - U.S. Food and Drug Administration

24-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution

Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution

The U.S. Food and Drug Administration is working with Mondelēz International, Inc., Pepperidge Farm Inc. and Flowers Foods, Inc. to initiate voluntarily recalls of certain products due to a potential risk that one of the ingredients may have been contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

23-7-2018

Flowers Foods Issues Voluntary Recall on Mrs. Freshley’s and Other Brands of Swiss Rolls and Captain John Derst’s Old Fashioned Bread

Flowers Foods Issues Voluntary Recall on Mrs. Freshley’s and Other Brands of Swiss Rolls and Captain John Derst’s Old Fashioned Bread

As a precautionary measure, Flowers Foods, Inc. (NYSE: FLO) is voluntarily recalling Swiss Rolls sold under the brand names Mrs. Freshley’s, Food Lion, H-E-B, Baker’s Treat, Market Square, and Great Value, distributed nationwide, and Captain John Derst’s Old Fashioned Bread distributed in Alabama, Florida, Georgia, North Carolina, and South Carolina, due to the potential presence of Salmonella in an ingredient, whey powder. The ingredient recall was initiated by a third-party whey powder manufacturer and...

FDA - U.S. Food and Drug Administration

23-7-2018

Mondelēz Global LLC Conducts Voluntary Recall of Certain Ritz Cracker Sandwiches and Ritz Bits Product in the U.S., including Puerto Rico & U.S. Virgin Islands Due to Possible Health Risk

Mondelēz Global LLC Conducts Voluntary Recall of Certain Ritz Cracker Sandwiches and Ritz Bits Product in the U.S., including Puerto Rico & U.S. Virgin Islands Due to Possible Health Risk

Mondelēz Global LLC announced today a voluntary recall in the United States, including Puerto Rico & the U.S. Virgin Islands, of certain Ritz Cracker Sandwiches and Ritz Bits product. These products contain whey powder as an ingredient, which the whey powder supplier has recalled due to the potential presence of Salmonella.

FDA - U.S. Food and Drug Administration

18-7-2018

FDA Investigating Multistate Outbreak of Salmonella Sandiego Infections Linked to Hy-Vee Spring Pasta Salad

FDA Investigating Multistate Outbreak of Salmonella Sandiego Infections Linked to Hy-Vee Spring Pasta Salad

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, is investigating a multi-state outbreak of Salmonella Sandiego illnesses linked to Spring Pasta Salad sold at Hy-Vee locations in Iowa, Illinois, Kansas, Minnesota, Missouri, Nebraska, South Dakota, and Wisconsin.

FDA - U.S. Food and Drug Administration

18-7-2018

Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses

Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses

WEST DES MOINES, Iowa (July 17, 2018) — Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its Hy-Vee Spring Pasta Salad due to the potential that it may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention last night when approximately 20 illnesses in Minnesota, South Dakota, Nebraska and Iowa were potentially linked back to customers consuming the salad. The voluntary recall includes Hy-Vee Spring Pasta Salads in both 1 pound (16 oz.) an...

FDA - U.S. Food and Drug Administration

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

22-6-2018

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

21-6-2018

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is recalling its NOW Real Food® Zesty Sprouting Mix – Product Code 7271, Lot #3031259 and Lot #3038165 – because its primary ingredient, Crimson Clover Seeds, has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may b...

FDA - U.S. Food and Drug Administration

15-6-2018

FDA Investigating Multistate Outbreak of Salmonella Mbandaka Infections Likely Linked to Kellogg’s Honey Smacks Cereal

FDA Investigating Multistate Outbreak of Salmonella Mbandaka Infections Likely Linked to Kellogg’s Honey Smacks Cereal

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Mbandaka illnesses that may be linked to Kellogg’s Honey Smacks cereal.

FDA - U.S. Food and Drug Administration

15-6-2018

Kellogg Company Voluntarily Recalls Honey Smacks Cereal Due to Possible Health Risk

Kellogg Company Voluntarily Recalls Honey Smacks Cereal Due to Possible Health Risk

Kellogg Company today announced it is voluntarily recalling 15.3 oz. and 23 oz. packages of Kellogg’s® Honey Smacks® cereal (with code dates listed below) because these products have the potential presence of Salmonella. No other Kellogg products are impacted by this recall.

FDA - U.S. Food and Drug Administration

9-6-2018

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods is voluntarily recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis, because these products have the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

9-6-2018

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Adelaide illnesses that may be linked to cut melons.

FDA - U.S. Food and Drug Administration

29-5-2018

Pious Lion Voluntary Recall Due to Possible Health Risk

Pious Lion Voluntary Recall Due to Possible Health Risk

Pious Lion located in Asheville, NC is voluntarily recalling two of their Kratom products: Pious Lion Pure Premium Potent Limited Release Pink Bali, 1 oz and Pious Lion Pure Premium Potent White Maeng DA, Bright Uplifting Energy, 4 oz due to the presence of Salmonella . Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhe...

FDA - U.S. Food and Drug Administration

23-5-2018

Golden International Corporation  Issues Public Safety Warning For Stolen Tilapia Because  of Possible Health Risk

Golden International Corporation Issues Public Safety Warning For Stolen Tilapia Because of Possible Health Risk

Golden International Corporation of Renton, WA is issuing a public safety notice for 405 cartons of stolen frozen tilapia, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection wi...

FDA - U.S. Food and Drug Administration

26-11-2018

Ixiaro (Valneva Austria GmbH)

Ixiaro (Valneva Austria GmbH)

Ixiaro (Active substance: Japanese Encephalitis vaccine (inactivated, adsorbed)) - Centralised - Renewal - Commission Decision (2018)7979 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/963/R/91

Europe -DG Health and Food Safety

22-8-2018

Leucogen (Virbac)

Leucogen (Virbac)

Leucogen (Active substance: Feline leukaemia vaccine (inactivated)) - Centralised - 2-Monthly update - Commission Decision (2018)5625 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/144/WS1282/6

Europe -DG Health and Food Safety

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

14-8-2018

Nobivac LeuFel (Virbac)

Nobivac LeuFel (Virbac)

Nobivac LeuFel (Active substance: Feline leukaemia vaccine (inactivated)) - Centralised - 2-Monthly update - Commission Decision (2018)5535 of Tue, 14 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4778/WS/1282/1

Europe -DG Health and Food Safety

7-8-2018

Intanza (Sanofi Pasteur Europe)

Intanza (Sanofi Pasteur Europe)

Intanza (Active substance: Influenza Vaccine (split virion, inactivated)) - Centralised - Withdrawal - Commission Decision (2018)5426 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

30-7-2018

UBAC (Laboratorios Hipra, S.A.)

UBAC (Laboratorios Hipra, S.A.)

UBAC (Active substance: Streptococcus uberis vaccine (inactivated)) - Centralised - Authorisation - Commission Decision (2018)5152 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4595

Europe -DG Health and Food Safety

25-7-2018

Respiporc Flu3 (IDT Biologika GmbH)

Respiporc Flu3 (IDT Biologika GmbH)

Respiporc Flu3 (Active substance: Inactivated vaccine against swine influenza in pigs) - Centralised - Yearly update - Commission Decision (2018)4991 of Wed, 25 Jul 2018

Europe -DG Health and Food Safety

25-7-2018

Nobivac L4 (Intervet International B.V.)

Nobivac L4 (Intervet International B.V.)

Nobivac L4 (Active substance: Canine leptospirosis vaccine (inactivated)) - Centralised - Yearly update - Commission Decision (2018)4990 of Wed, 25 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

ERYSENG (Laboratorios Hipra, S.A.)

ERYSENG (Laboratorios Hipra, S.A.)

ERYSENG (Active substance: Inactivated Erysipelothrix rhusiopathiae, strain R32E11) - Centralised - Yearly update - Commission Decision (2018)4523 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Active substance: Inactivated porcine parvovirus, strain NADL-2 / Inactivated Erysipelothrix rhusiopathiae, strain R32E11) - Centralised - Yearly update - Commission Decision (2018) 4354 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

29-6-2018

Porcilis PCV M Hyo (Intervet International B.V.)

Porcilis PCV M Hyo (Intervet International B.V.)

Porcilis PCV M Hyo (Active substance: Porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated)) - Centralised - 2-Monthly update - Commission Decision (2018)4166 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/3796/II/7

Europe -DG Health and Food Safety

20-6-2018

Rhiniseng (Laboratorios Hipra, S.A.)

Rhiniseng (Laboratorios Hipra, S.A.)

Rhiniseng (Active substance: inactivated vaccine against atrophic rhinitis in pigs) - Centralised - Yearly update - Commission Decision (2018)3952 of Wed, 20 Jun 2018

Europe -DG Health and Food Safety

19-6-2018

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Active substance: purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir, SAT2 Saudi Arabia) - Centralised - Renewal - Commission Decision (2018)3891 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2292/R/8

Europe -DG Health and Food Safety