Tuberculin PPD Kit

Main information

  • Trade name:
  • Tuberculin PPD Kit
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Tuberculin PPD Kit
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Avian tuberculin PPD
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0342/001
  • Authorization date:
  • 24-01-2012
  • EU code:
  • UK/V/0342/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:November2012

AN:00636/2012

Page1of8

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEIMMUNOLOGICALVETERINARYMEDICINALPROCUCT

TuberculinPPDKit

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

BovineTuberculinPPD3000:

Per0.1ml(1dose):

Activesubstance:

BovineTuberculinpurifiedproteinderivativefromcultureofMycobacterium

bovis,strainAN53000IU*

Otherexcipients:

Phenol: 0.4 –0.5mg

Forafulllistofexcipients,seesection6.1

AvianTuberculinPPD2500:

Per0.1ml(1dose):

Activesubstance:

AvianTuberculinpurifiedproteinderivativefromcultureofMycobacterium

aviumsubspeciesavium,strainD4ER 2500IU*

Otherexcipients:

Phenol: 0.4 –0.5mg

Ponceau4R(E124): 5microgram

Forafulllistofexcipients,seesection6.1

(*IU:InternationalUnitsaccordingtoPh.Eur.)

3. PHARMACEUTICALFORM

Solutionforinjection

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle.

Revised:November2012

AN:00636/2012

Page2of8

4.2 Indicationsforuse,specifyingthetargetspecies

Tobeusedforthein-vivoidentificationofcattlewhichhavebeenexposedto

Mycobacterium species causing bovine tuberculosis. Simultaneous

administrationofBovineTuberculinPPD3000andAvianTuberculinPPD

2500andcomparingthedegreeofskinswellingofthetwoinjectionsites

enablesdifferentiationbetweenthespecificreactionintargetspeciesexposed

toMycobacteriumspeciescausingbovinetuberculosisandthenon-specific

reactionintargetspecies,whichhavebeenexposedtootherspeciesof

Mycobacteriaorrelatedgenera,causingcrosssensitisationtoBovine

TuberculinPPD3000.

4.3 Contra-indications

None

4.4 Specialwarnings

ForareliableresultoftheSingleIntradermalComparativeCervicalTuberculin

(SICCT)testtheuseoftheTuberculinPPDKitincattleshouldbeavoided

within42daysfollowingapreviousadministrationoftuberculinPPDs.In

specificcircumstances,atimeintervalshorterthan42daysmaynotbe

avoidede.g.whenaherdundergoingtestmayincluderecentlyacquired(and

tested)animals.However,ithasbeenobservedthatashortertimeinterval

betweentestsresultsinapotentiallossofskinresponsivenessandis

thereforenotrecommended.

Thereliabilityofthetestdependsupontheproperintradermalinjectionofthe

tuberculinPPDs(BovineandAvianTuberculinPPDs)togetherwiththe

accuratemeasurement,characterisation,andcomparisonoftheskinreactions

72hourslater.Subcutaneousinsteadofintradermalinjectionoftuberculin

PPDsmaygiverisetoafalseresultandisalsolikelytoleadtodesensitisation

oftheanimalforavariableperiod.

Thereliabilityofthetestisalsoinfluencedbythesiteofinjectionofthe

tuberculinPPD(see4.9)andbytheamountoftuberculinPPDadministered;

doseslessthantheprescribedamountof0.1mlarelikelytoleadtoafalse

resultoftheSICCTtest.

Thesensitivityofthetestcanbeinfluencedbyconcurrentinfectionwith

Mycobacteriumspeciesthatdonotcausebovinetuberculosis.Theinterval

sinceinfectionwithMycobacteriumspeciescausingbovinetuberculosis,either

whereanimmuneresponsehasnothadsufficienttimetodevelop,orwhere

theimmuneresponseperiodhasbeensuperseded,mightalsocontributetoa

lowersensitivity.Noticemustbetakenthattheresponseisordinarily

somewhatdepressedintheperi-parturientperiod.

Intheeventofafulminatinginfectionaresponsetotheintradermaltestcan

evenbeabsent.

Revised:November2012

AN:00636/2012

Page3of8

4.5 Specialprecautionsforuse,includingspecialprecautionstobetakenby

thepersonadministeringtheimmunologicalveterinarymedicinal

product

i. Specialprecautionsforuseinanimals

None

ii. Specialprecautionstobetakenbythepersonadministeringthe

immunologicalveterinarymedicinalproduct

Incaseofaccidentalself-injectionpersonswhohavebeenexposedto

tuberculinprotein,eitherfromaprevioustuberculosisvaccination,or

fromenvironmentalexposuremayexpectareaction.Over48to72

hoursthiswillcauseaskinreactionofahard,densewheal.Mild

itching,swelling,orirritationatthesiteoftheinjectionarefrequent

reactions.Ifastrongreactionorsystemicsymptomsoccurseekmedical

adviceimmediately.Showthepackageleafletorthelabeltothe

physician.

iii. Otherprecautions

Diseasespreadprecautions

Personalprotectiveequipmentconsistingofsuitableprotectiveclothing

andfootwearshouldbewornwhenconductingtuberculintests.All

practicablemeasuresofcleaninganddisinfectionofprotectiveclothing,

footwear,handsandequipment(syringes,etc.)shouldbeundertaken

onentryandexitfromtheholdingtominimisetheriskofdisease

transfer.

4.6 Adversereactions

Aswellingoftheskinisverycommonattheinjectionsitesshortlyafterthe

administration,inparticularincattleinfectedwithMycobacteriumbovis.In

uninfectedanimalsthisswellingwillgreatlydecreaseinsizewithin24hours

andcompletelydisappearwithin3to4days,unlesstheanimalhasbecome

sensitisedtootherspeciesofMycobacteriacapableofcausinganon-specific

reaction.Ininfectedcattleand/orincattlesensitisedwithnon-specific

mycobacteriatheinitialswelling,inuncommoncasesupto65mm,willalso

decreaseinsizewithin24hoursbutitwilltakeupto4weeksbeforethe

swellinghascompletelydisappeared.Ininfectedcattleasmallriseinbody

temperature,whichwillreturntonormalwithin24hours,canoccurbutis

uncommon.

4.7 Useduringpregnancy,lactationorlay

Althoughnospecificlaboratorysafetytestsweredoneinpregnantorlactating

cattle,experiencefromfielduseindicatethattheadministrationofBovine

Revised:November2012

AN:00636/2012

Page4of8

and/orAvianTuberculinPPDdoesnothaveanegativeeffectonreproductive

performanceorlactation.

4.8 Interactionwithotherveterinarymedicinalproductsandotherformsof

interaction

InjectionofotherproductsatoradjacenttothesiteoftuberculinPPDinjection

shouldbeavoidedduringtheperiodimmediatelypriortotuberculinPPD

injectionanduntilthecompletionofthereadingofthetuberculintest.Possible

reactionsduetosuchotherproductscouldbeconfusedwith,orotherwise

affect,thedelayedtypehypersensitivityreactionduetotheadministrationof

tuberculinPPDs.

Whereadministrationofamedicinalproductisnecessarysuchproductshould

notbeadministeredneartotheinjectionsitesoftheTuberculinPPDKitand

preferablynotonthesamesideoftheneck.

Ingeneralitisrecommendedthatnootherveterinarymedicinalproductshould

beadministeredbeforeandafteradministrationoftheTuberculinPPDKit.

Inparticular,theTuberculinPPDKitshouldnotbeusedincattlewhich

recentlyhavebeentreatedwithimmunosuppressivemedicinessuchas

glucocorticosteroidssincesuchatreatmentmayinfluencetheresultsofthe

tuberculintest.

Amoresevereinterpretationofthetuberculinskintestmayberequiredin

animalsvaccinatedagainstJohne’sDisease(paratuberculosis),asvaccination

couldgiverisetofalsenegativeSICCTtestresultsinsuchanimals.

N.B.Vaccinationofcattleagainstbovinetuberculosisiscurrentlyforbiddenin

theEuropeanUnion.

4.9 Amountstobeadministeredandadministrationroute

Selectionofsitesofinjection:

Theapprovedinjectionsitesaresituatedattheborderoftheanteriorand

middlethirdsofeithersideoftheneck.Inadultanimalstheuppersiteisabout

fourinches(10cm)belowthecrest.Thelowersiteshouldbeaboutfiveinches

(12.5cm)fromtheuppersite,onalinedrawnparallelwiththelineofthe

shoulder.Inyounganimalswherethereisinsufficientspacetoinjectboth

tuberculinPPDsintothesamesideoftheneck,thetuberculinPPDsshouldbe

injected,oneoneachsideoftheneck,atcorrespondingsitesinthecentreof

themiddlethirdoftheneck.Inanimals,whichhavenon-associatedlumpsor

swellingsproximaltotheinjectionsite(s)thetuberculinPPDshouldbeinjected

intotheoppositesideoftheneck.

Preparationofsitesofinjection:

Theselectedsitesofinjectionshouldbeclipped(anadequatelysizedareafor

identificationoftheinjectionsites),cleansed(withwateralone)ifobviously

dirty,anddebrisshouldberemovedpriortoinjection.Thepresenceofany

Revised:November2012

AN:00636/2012

Page5of8

abnormalitiesneartotheinjectionsite(s)shouldberecorded.Thepresenceof

skintuberculosisshouldalsoberecorded.

Measurementofskinthicknesspriorinjection:

Beforeinjection,afoldofskinateachoftheintendedinjectionsitesandwithin

theclippedareamustbetakenbetweentheforefingerandthumband

accuratelymeasuredtothenearestmillimetreusingcallipers.

Intradermalinjection:

Acorrectintradermalinjectiontechniqueandthedeliveryoftheprescribed

dosevolumeof0.1mlperinjectionareimportantforareliabletestresult.A

correctinjectionisconfirmedbypalpatingasmallpea-likeswellingateach

injectionsite.Ifthereisanydoubtabouteitheroftheinjectionsbeingdelivered

intradermally,afurtherinjectionshouldbemade,preferablyata

correspondingsiteontheothersideoftheneck.

Readingofthetuberculintestafterinjection:

Theinjectionsitesshouldbepalpatedcarefullytodetectreactions72hours

(+/-4hours)afterintradermalinjectionandtheskin-foldthicknessofeach

injectionsitere-measured.Thesamepersonshouldmeasuretheskinbefore

theinjectionandwhenthetestisread.

Measurementsoftheinjectionsitemustbetakencarefullybyplacingthe

callipers,wherearesponse(swelling)hasbeendetected,acrossthebroadest

widthoftheswelling,withoutapplyingunduepressure.

Clinicalsignscompatiblewithbovinetuberculosismustberecordedatthe

timeofreadingtoassistintheidentificationofanimalsthatmaybeexposed

butwhichhavenotbeenidentifiedasreactorsintheSICCTtest(i.e.false

negatives).

Thepresenceofclinicalsigns,suchasdiffuseorextensiveoedema,

exudation,necrosis,painatthesiteoftestorswellingoftherelatedpre-

scapularlymphnode,isalwaysindicativeoflikelyexposuretoMycobacterium

speciescausingbovinetuberculosis.Animalsshowingsuchreactionsmust

alwaysbedeemedasreactors,irrespectiveoftheskin-foldmeasurements

recorded.

InterpretationoftheSingleIntradermalComparativeCervicalTuberculin

(SICCT)test:

Fortheestablishmentandmaintenanceofofficiallytuberculosis-freeherd

statusforthepurposeofinternalEUtradinginbovines,theinterpretationof

theskinreactionsinducedbythebovineandaviantuberculinPPDinjections

shouldbemadeaccordingtothefollowinginstructions(asdescribedinsection

2.2.5.3.2ofAnnexBofCouncilDirective64/432/EEC).

Revised:November2012

AN:00636/2012

Page6of8

Interpretationof

skinreactionsof

theSICCTtest Clinicalobservationsandtherecordedincreasesinskin-

foldthicknessatthesitesofinjection72hoursafter

injectionoftheTuberculinPPDs.

Positivereaction

AreactiontobovinetuberculinPPDwhichismorethan4mm

greaterthanthereactiontoaviantuberculinPPD,orthe

presenceofclinicalsigns.

Inconclusive

reaction

AreactiontobovinetuberculinPPD(ofatleast2mm)which

isfrom1to4mmgreaterthanthereactiontoaviantuberculin

PPD,andtheabsenceofclinicalsigns.

Negativereaction

AreactiontobovinetuberculinPPDwhichisequaltoorless

thanthereactiontoaviantuberculinPPD,andtheabsenceof

clinicalsigns.

AnimalsinconclusivetotheSICCTtestthatarenotremoved,eithervoluntarily

bytheanimalownerorbythecompetentauthority,shallbesubjectedto

anothertestafteraminimumof42days.Animals,whicharenotnegativeto

thissecondtest,shallbedeemedpositivetothetest.

Nationalrequirementsforamoresevereinterpretationoftheskinreactions

mayapply.

4.10Overdose(signs,emergencyprocedure,antidotes),ifnecessary

Thereactionsseenafteradministrationofanoverdosearethesameasthose

describedunder4.6.

4.11Withdrawalperiods

Zerodays

5. IMMUNOLOGICALPROPERTIES

ATCvetcode(s):

BovineTuberculinPPD3000:QI02AR01

AvianTuberculinPPD2500:QI02AR02

Theseproductsareinvivodiagnosticsubstancestodiagnosethestateof

immunityofcattleagainstbovinetuberculosis.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Phenol

Glucoseanhydrous

Disodiumphosphatedihydrate

Potassiumdihydrogenphosphate

Waterforinjections

Revised:November2012

AN:00636/2012

Page7of8

Ponceau4R(E124)*

*ThecolouringagentPonceau4R(E124)isonlypresentinAvianTuberculin

PPD2500.

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3 Shelf-life

Shelf-lifeoftheimmunologicalveterinarymedicinalproductaspacked

forsale:

TheTuberculinPPDKitcomprisestwocomponentseachwithadifferentshelf-

life.

Shelf-lifeofthe20-dosespresentation:

BovineTuberculinPPD3000:2½years

AvianTuberculinPPD2500:2years

Shelf-lifeofthe50-dosespresentation:

BovineTuberculinPPD3000:1½years

AvianTuberculinPPD2500:1½years

Theshelf-lifeoftheTuberculinPPDKitisspecifiedastheshelf-lifeofthe

componentwiththeearliestexpirydate.

Shelf-lifeafterfirstopeningofthecontainer:

Shouldbeusedimmediatelyafterfirstopening.

6.4 Specialprecautionsforstorage

Storeinarefrigerator(+2°C-+8°C).Donotfreeze.

Keepthevialsinthepolystyrenebox,closedwithcartonsleeve,inorderto

protectfromlight.

Transportation:

Maybetransportedat+2°C-+37°Cforaperiodnotlongerthan14days.Do

notfreeze.

Keepthevialsinthepolystyrenebox,closedwithcartonsleeve,inorderto

protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

The20-dosespresentationoftheTuberculinPPDKit:

Polystyreneboxwith20vials(hydrolyticTypeI)ofBovineTuberculinPPD

3000and20vials(hydrolyticTypeI)ofAvianTuberculinPPD2500.Eachvial

contains20dosesof0.1ml.

The50-dosespresentationoftheTuberculinPPDKit:

Polystyreneboxwith10vials(hydrolyticTypeI)ofBovineTuberculinPPD

3000and10vials(hydrolyticTypeI)ofAvianTuberculinPPD2500.Eachvial

contains50dosesof0.1ml.

Revised:November2012

AN:00636/2012

Page8of8

Thevialsareclosedwitharubber-butylstopperandsealedwithanaluminium

cap(blankcapforBovineTuberculinPPD3000andredcapforAvian

TuberculinPPD2500).Theboxisclosedwithalabelledcartonsleeve.A

packageleafletisincluded.

6.6 Specialprecautionsforthedisposalofunusedimmunologicalveterinary

medicinalproductsorwastematerialsderivedfromtheuseofsuch

products

Anyunusedproductorwastematerialderivedfromsuchproductsshouldbe

disposedofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

PrionicsLelystadBV

Platinastraat33

8211ARLelystad

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

Vm 36410/4000

9. DATEOFTHEFIRSTAUTHORISATION

Date:24November2010

10. DATEOFREVISIONOFTHETEXT

Date:November2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Theimport,sale,supplyand/oruseoftheTuberculinPPDKitmaybeprohibitedin

certainMemberStatesonthewholeorpartoftheirterritorypursuanttoNational

AnimalHealthpolicy.Anypersonintendingtoimport,sell,supplyand/orusethe

TuberculinPPDKit hastoconsulttherelevantMemberStates’Competent

Authoritiesonthecurrentpoliciespriortoimport,sale,supplyand/oruse.

Approvedby: 20/11/12

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

28-11-2018

Allergen Alert: Kitchen Cravings Strawberry and Mixed Berry Parfaits with Trace Tree Nuts

Allergen Alert: Kitchen Cravings Strawberry and Mixed Berry Parfaits with Trace Tree Nuts

Kwik Trip, Inc. located in La Crosse, WI is recalling Kitchen Cravings Strawberry and Mixed Berry Parfaits in an 8.25 oz. cup because they may contain undeclared traces of cashews or almonds

FDA - U.S. Food and Drug Administration

14-11-2018

Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade

Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade

Nor Cal Food Solutions, LLC of Auburn, CA is announcing a recall of 567 cases of Pumpkin Pesto Tapenade, manufactured by Purveyors Kitchen, because it contains an undeclared tree nut (walnut). People who have an allergy or severe sensitivity to tree nuts (walnuts) run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

14-8-2018

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Health Canada’s sampling and evaluation program has determined the Do-It-Yourself Slime Kits do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

26-7-2018

Medical Devices Safety Update Volume 6, Number 4, July 2018

Medical Devices Safety Update Volume 6, Number 4, July 2018

Be aware of cross-reactivity with home-use self-test ovulation kits, TGA undertakes product safety review into intragastric balloon systems

Therapeutic Goods Administration - Australia

19-7-2018

Makita Canada Inc. recalls Makita and Dolmar Chainsaws

Makita Canada Inc. recalls Makita and Dolmar Chainsaws

The automatic chain brake does not easily engage when the saw kicks back, possibly exposing the user to contact with the chain while it is still moving, posing a laceration hazard.

Health Canada

17-7-2018

ALDI Voluntarily Recalls AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits Due to Storage at Incorrect Temperature in Area Store

ALDI Voluntarily Recalls AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits Due to Storage at Incorrect Temperature in Area Store

Batavia, Ill. Uuly 14, 2018) -ALDI has voluntarily recalled AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits sold at one retail store location in North Carolina. While the products are required to remain at frozen temperatures to ensure safety, this store location displayed and sold the products from the cooler section. Because storing the products at temperatures above freezing prior to consumption can render the products unsafe for consumption, ALDI is recalling these items.

FDA - U.S. Food and Drug Administration

13-7-2018

AZ Firm Issues Voluntary Product Recall Due to Undeclared Peanuts in Superfood Salad

AZ Firm Issues Voluntary Product Recall Due to Undeclared Peanuts in Superfood Salad

Papa John’s Salads and Produce of Tolleson, AZ is voluntarily recalling 148 units of the Superfood Salads due to misbranding and undeclared peanuts. The product contains peanuts which are not declared on the product label as packages of peanuts were mistakenly included in the kits instead of cashews.

FDA - U.S. Food and Drug Administration

6-7-2018

Pseudomonas Aeruginosa Bacteria Found In Saje Splish Splash Gentle Baby Wash

Pseudomonas Aeruginosa Bacteria Found In Saje Splish Splash Gentle Baby Wash

Saje Natural Wellness is warning customers not to use Splish Splash Gentle Baby Wash, 8.5 fl. oz. and 1.7 fl. oz. (found in the Wee and Well Gentle Baby Care Kit) as it may contain the bacteria Pseudomonas aeruginosa. Pseudomonas aeruginosa is an opportunistic pathogen that causes infection and results in bacteria in the blood, particularly in individuals with compromised immune systems.

FDA - U.S. Food and Drug Administration

14-6-2018

Blokhuis: maak postnatale depressie bespreekbaar

Blokhuis: maak postnatale depressie bespreekbaar

In Nederland ontwikkelen jaarlijks ruim 23.400 vrouwen een depressie na de bevalling. Dat is 1 op de 8 moeders. Velen van hen durven hun situatie niet aan te kaarten. Zij zijn bang om gezien te worden als een slechte moeder (47,4%) en willen anderen niet belasten (52,2%), blijkt uit een peiling onder vrouwen die (signalen van) een postnatale depressie hebben gehad. Hierdoor blijft postnatale depressie, ook wel postpartum depressie (PPD) genoemd, te vaak onbesproken. Daarom geeft staatssecretaris Paul Blo...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

26-5-2018

Shadow Holdings, LLC Issues Voluntary Nationwide Recall of X-Jow and Acne Shave products due to Possible Bacterial Contamination

Shadow Holdings, LLC Issues Voluntary Nationwide Recall of X-Jow and Acne Shave products due to Possible Bacterial Contamination

Shadow Holdings is voluntarily recalling all lots, within expiry, of Herb-X Solutions X-Jow Pain Gel, and United Exchange Acne Shave Moisturizer, Acne Shave Shave Cream with Acne Shield, and Acne Shave Shave Kit to the retail level. The products may be contaminated with bacteria.

FDA - U.S. Food and Drug Administration

17-5-2018

The Michaels Companies, Inc. recalls Creatology Pottery Wheel Kit and Creatology Spin Art Kit

The Michaels Companies, Inc. recalls Creatology Pottery Wheel Kit and Creatology Spin Art Kit

Internal wiring within the product may overheat posing a risk of burns or fire.

Health Canada

11-5-2018

Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical: Class I Recall - Due to Risk of Malfunction Caused by Error in Product Design

Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical: Class I Recall - Due to Risk of Malfunction Caused by Error in Product Design

Vyaire Medical is recalling the AirLife Resuscitation Device & Broselow Convenience Kit due to an error in its product design that may result in difficultly or the inability to disconnect the mask from the elbow of the resuscitator.

FDA - U.S. Food and Drug Administration

7-5-2018

Viibryd Starter Kit (10 & 20 mg)

Viibryd Starter Kit (10 & 20 mg)

Health Canada

4-5-2018

 Slime: a very popular toy putty that is not without risk

Slime: a very popular toy putty that is not without risk

ANSES and the DGCCRF are alerting consumers to the risks associated with making and handling "slime". Slime, a sticky and elastic putty for kneading, is currently very popular with children and adolescents. It is commercially available in ready-to-use form or in kits. It can also be made at home, in order to vary its appearance and texture (by adding colour, glitter, etc.). Tutorials on how to make slime have proliferated on the Internet and offer many recipes, based on ingredients such as paper glue and...

France - Agence Nationale du Médicament Vétérinaire

30-4-2018

Stonewall Kitchen Voluntarily Recalls a Limited Amount of Basil Pesto Aioli due to Mislabeling and Undeclared Presence of the Dairy Allergen, Egg

Stonewall Kitchen Voluntarily Recalls a Limited Amount of Basil Pesto Aioli due to Mislabeling and Undeclared Presence of the Dairy Allergen, Egg

Stonewall Kitchen is voluntarily recalling a limited amount of 10.25oz Basil Pesto Aioli with an Enjoy By date of 28 Sep 2019 which may contain the undeclared allergen egg, as we may have inadvertently placed the label for our Basil Pesto on a small portion of our most recent production run.

FDA - U.S. Food and Drug Administration

22-1-2018

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Ocean Township, NJ. In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration ("FDA") to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks.

FDA - U.S. Food and Drug Administration

24-9-2018

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments:  https://go.usa.gov/xPjKX pic.twitt

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments: https://go.usa.gov/xPjKX pic.twitt

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments: https://go.usa.gov/xPjKX  pic.twitter.com/iQsKIAAQTn

FDA - U.S. Food and Drug Administration

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

1-8-2018

Cyanokit (SERB S.A.)

Cyanokit (SERB S.A.)

Cyanokit (Active substance: hydroxocobalamin) - Centralised - Yearly update - Commission Decision (2018)5229 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2038 (PPD Global Ltd)

EU/3/18/2038 (PPD Global Ltd)

EU/3/18/2038 (Active substance: Palovarotene) - Orphan designation - Commission Decision (2018)4183 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/025/18

Europe -DG Health and Food Safety

11-6-2018

SomaKit TOC (Advanced Accelerator Applications)

SomaKit TOC (Advanced Accelerator Applications)

SomaKit TOC (Active substance: edotreotide) - Centralised - Yearly update - Commission Decision (2018)3762 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety