Aquaflor 500 mg premix for medicated feeding stuff

Main information

  • Trade name:
  • Aquaflor 500 mg premix for medicated feeding stuff
  • Pharmaceutical form:
  • Premix for medicated feed
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Aquaflor 500 mg premix for medicated feeding stuff
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • florfenicol
  • Therapeutic area:
  • Fish Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0250/001
  • Authorization date:
  • 24-10-2012
  • EU code:
  • FR/V/0250/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Aquaflor500mg/gpremixformedicatedfeedingstuff forrainbowtrouts

Spain:FlorocolAqua500mg/gpremixformedicatedfeedingstuff forrainbowtrouts

Finland:Aquaflorvet500mg/gpremixformedicatedfeedingstuff forrainbowtrouts

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1gpremixcontains:

Activesubstance:

Florfenicol 500mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Premixformedicatedfeedingstuff.

Awhitefreeflowingpowder.

4. CLINICALPARTICULARS

4.1 Targetspecies

Rainbowtrout(Oncorhynchusmykiss)

4.2 Indicationsforuse,specifyingthetargetspecies

ForthetreatmentandpreventionoffurunculosisinrainbowtroutcausedbyAeromonassalmonicida

susceptibletoflorfenicolinfreshwaterfisheries.Thepresenceofthediseaseshouldbeestablishedin

theholdingunitbeforeinitiatingthetreatment. Useoftheproductshouldbebasedonsusceptibility

testingofthebacteriaisolatedfromtheanimal.

4.3 Contraindications

Donotuseinbroodstock.

Donotuseinanimalswithknownhypersensitivitytotheactiveingredient.

Donotadministertogetherwithotherantimicrobialproducts.

4.4 Specialwarningsforeachtargetspecies

Inordertomaximizefeeduptakethroughoutthepopulationtobetreated,medicatedfeedshouldbe

administeredfollowingthesamefeedingregimenaswasusedpriortotreatment,tothegreatestdegree

possible.Careshouldbetakenwhenadministeringmedicatedfeedbyhandthatfeedpelletsarewidely

dispersedtominimizehierarchicalfeedingbehavior.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromtheanimal.If

thisisnotpossible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiological

informationaboutsusceptibilityofthetargetbacteria.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttoflorfenicol.

Theproductshouldonlybeusedinfreshwaterfisheries. Benefit-riskanalysishasbeenconsidered

favorablewhentheproductisusedasindicatedforfurunculosisintroutinfreshwater.Benefitrisk

analysishasnotbeenfullyperformedforuseinmarineaquaculture,especiallywithregardsto

environmentalrisk. Afullbenefit-riskanalysishasnotbeenperformedforuseinmarineaquaculture.

Theuseoftheproductshouldalwaysbecombinedwithgoodmanagementpracticesofthefreshwater

fisheries(e.g.vaccinationprogrammes,biosecurity,waterqualityandsitehygiene).

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Weareitheradisposablehalf-maskrespiratorconformingtoEuropeanstandardEN149oranon-

disposablehalf-maskrespiratortoEuropeanStandardEN140withafiltertoEN143(locallyavailable

equivalenthalf-maskrespirator),chemicallyresistantgloves,protectivecoverallsandsafetyglasses

whileincorporatingthepremixintothefeed.

Wearglovesanddonotsmokeoreatwhilehandlingtheproductormedicatedfeed.Washhands

thoroughlywithsoapandwaterafteruseoftheproductormedicatedfeed.Thoroughlycleanall

equipmentusedinmedicatingfeed.

Incaseofaccidentalself-ingestionseekmedicaladviceimmediatelyandshowthelabeltothe

physician.

Peoplewithknownhypersensitivitytotheactiveingredientshouldavoidcontactwiththeveterinary

medicinalproduct.

4.6 Adversereactions(frequencyandseriousness)

None.

4.7 Useduringpregnancy,lactationorlay

Notapplicable.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

In-feeduse.Forthepreparationofmedicatedfeedingstuff.

Aquaflorpremixshouldbemixedintooronfeedtodeliveratotaldailydoserateof10mgof

florfenicolperkgbodyweightduring10consecutivedays.

Theentiredailyrationofmedicatedfeedshouldbeadministeredfirstforeachdayofthe10-day

dosingperiod.Ifthefeedingrateexceeds0.4%ofthebiomass,non-medicatedfeedmaybe

administeredafterthemedicatedration.Ifthefeedingrateis≤0.4%ofthebiomass,thenthedaily

rationshouldconsistofonlymedicatedfeedandbeadministeredatonetime.

Administrationofmedicatedfeedshouldbeginimmediatelyfollowingdiagnosistoensurethatfishare

abletoconsumethecompletemedicatedration.

Thisproductshouldbeincorporatedbylicensedfeedmanufacturersonly.Theconcentrationof

medicatedpremixinfeedshouldbeatleast≥0.5%or5kgpremix/tonfeed.

MixingInstructions:

Duringthepreparationofmedicatedfeed,thepremixiseithercoatedontothesurfaceofthepelletor

incorporatedintothefeedingredientmashpriortoextrusionorpelleting.

Top-coating:

Method1:Thedrypremixisthoroughlymixedwithfeedwhichtypicallycontains24–38%w/w

lipid.Approximately0.5%w/woilisthenaddedtothepremix/feedmixturetoimprovebothpremix

adhesionandpalatability.

a) Addknownquantityoffishfeedintoamixer.

b) Weighthepremix.

c) Mixpremixwithfeedpellets.

d) Medicatedfeedpelletsaremixed/coatedwithapredeterminedamountoffishorvegetableoil.

e) Atthecompletionofmixing,theproductistransferredtoastoragetankforpackagingor

transport.

Method2:Thedrypremixismixedwithoil.Thepremix/oilpreparationisthenaddedtothefeedto

producepalatablemedicatedfeedpellets.

a) Weighoutfishorvegetableoilintoabucket.

b) Weightoutthepremixandmixthoroughlywithoilinthebucket

c) Addaknownquantityoffishfeedintoamixer.

d) Addthepremixandoilmixturetothefeedinthemixer,slowly,whilethemixerisrunningat

lowspeed.Atthecompletionofmixing,theproductistransferredtoastoragetankfor

packagingortransport.

ExtrusionorPelleting:

Thedrypremixisaddeddirectlytothefeedingredientmashandmixedthoroughly.Waterandsteam

areadded,andthecompletemixtureisthenextrudedorpelleted,driedandpacked.

a) Thepremixisaddeddirectlytothefeedingredientmashandmixedthoroughlytoensure

homogeneity.

b) Themixtureissteampelletedandorextrudedandthepelletsaredried.

c) Medicatedfeedpelletsaremixed/coatedwithapre-determinedamountoffishorvegetableoil.

d) Atthecompletionofmixing,theproductistransferredtoastoragetankforpackagingor

transport.

RecommendedAquaflorpremixinclusionrateforpreparationofmedicatedfeed

FeedingRate AmountofAquaflor

PremixperMetric

TonneofFeed AmountofFlorfenicol

perFeedinmg/kg KilogramsofFishMedicatedper

MetricTonneofFeed(1000kg)for

10-dayTreatmentPeriod

%Biomass kg mg kg

0,4 5,0 2.500 25.000

0,3 6,7 3.333 33.333

0,2 10 5.000 50.000

Theformulaforcalculationoftheamountofpremixtobeaddedtofeedtoproducemedicatedfeedat

≥5kgpremix/tonfeedisasfollows:

20mgpremix(=10mgflorfenicol) Averagefishweight

perkgbodyweightandday x (kg) ═mgpremixperkgoffeed

Averagedailyfeedintake(kg/fish)

4.10Overdose

Noadversereactionswereobservedaftertreatmentofrainbowtroutwith5timestherecommended

doseofflorfenicol.

4.11Withdrawalperiods

135degreedays

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialforsystemicuse,Amphenicols,florfenicol

ATCvetcode:QJ01BA90

5.1 Pharmacodynamicproperties

Florfenicolisasyntheticbroad-spectrumantibioticeffectiveagainstmostGram-positiveandGram-

negativebacteriaisolatedfromdomesticanimals.Florfenicolactsbyinhibitingproteinsynthesisatthe

ribosomallevel.Laboratorytestshaveshownthatflorfenicolisactiveagainstthemostcommonly

isolatedbacterialpathogensinvolvedinfishdiseasesnotablyAeromonassalmonicida.Florfenicolis

consideredtobeabacteriostaticagent,butinvitrostudiesofflorfenicoldemonstratetime-dependent

bactericidalactivityagainstAeromonassalmonicida.

AtpresenttherearenoacceptedinterpretivecriteriaforflorfenicolMICdataofbacteriafrom

aquaculture.However,avalueof≤4μg/mLhasbeenadoptedbyCLSI(2006)astheepidemiological

cut-offvalueforthedeterminationofthewild-typepopulation.Aeromonassalmonicidastrainswitha

MIC≤2µg/mLareconsideredsusceptibletoflorfenicolthroughoutEurope.

Surveillancedataofthesusceptibilityoftargetfieldisolatesfromfishcollectedbetween1995and

2009acrossEuropeshowaMICrangeof0.12–32µg/mlandaMIC

of1µg/ml andlowpercentage

ofnon-wild-typeisolates. Co-resistancetowardsotherclassesofantimicrobialsandcross-resistanceto

chloramphenicolhasbeendescribedforfishpathogens.

FlorfenicolresistanceinGram-negativebacteriahasbeendetectedandisrelatedtoplasmidtransferof

theflogene.Thisgenecodesforamembrane-associatedexporterproteinthatpromoteseffluxof

chloramphenicolandflorfenicol. Thiscanbelocatedonplasmidscarryingresistancetoantimicrobials

fromotherclasses,thereforeuseoftheproductcanselectforco-resistance.

Cross-resistanceislimitedduetothesubstitutionofahydroxylgroupwithafluorinemolecule.

Therefore,florfenicolislesssusceptibletoresistancefrombacteriaexpressingchloramphenicolacetyl

transferaseenzymes.

Becauseofthesubstitutionofahydroxylgroupwithafluorinemolecule,florfenicolislesssusceptible

toresistancefrombacteriaexpressingchloramphenicolacetyltransferaseenzymes.

5.2 Pharmacokineticparticulars

Pharmacokineticstudieshavebeenconductedwithflorfenicolfollowingasingleoraladministrationof

10mg/kgbodyweighttorainbowtroutat10°Cand16°C.Afteroraladministrationofmedicated

feedcontainingflorfenicol,peakplasmaconcentrationsofrespectively3.0and3.7µg/mlwere

reached13.7and10.9hoursafteradministrationat10°Cand16°C.Florfenicolhadanoral

bioavailabilityof73.9%at10°Cand66.3%at16°C.

Pharmacokineticparametersfollowingasingleintravenousadministrationof10mg/kgbodyweight

were:apparentvolumeofdistributionatsteadystateV

d(ss) of0.909l/kg,totalbodyclearanceCl

of

0.075l/handtheeliminationhalf-lifeT

½β of8.8hours.Thesevaluesindicatethedrugwaswell

distributed.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Lactosemonohydrate

PovidoneK29/32

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackedforsale:2years

Shelflifeafterfirstopeningtheimmediatepackaging:3months

Shelflifeafterincorporationintomealorpelletedfeed:3months

6.4.Specialprecautionsforstorage

Premix:Themedicinalproductdoesnotrequireanyspecialstorageconditions.

Storeinadryplace.

Keepseparatefromfeedsandfoodstuffs.

Medicatedfeed:Donotstoreattemperaturesabove25°C.

6.5 Natureandcompositionofimmediatepackaging

2kglaminatedsachetconsistingofpolypropylene/lowdensitypolyethylene/aluminiumfoil/Surlyn

ionomerheatsealant. Laminatedsachetconsistingofpolypropylene/lowdensitypolyethylene/aluminium

foil/Surlynionomerheatsealant. Eight2kgsachetsarepackedinafibredrum.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialderivedfromsuchveterinarymedicinalproductshouldbedisposed

ofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

IntervetInternationalB.V.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

LABELLINGANDPACKAGELEAFLET

A.LABELLING

NOTAPPLICABLE

B.PACKAGELEAFLET

PACKAGELEAFLET

Aquaflor500mg/gpremixformedicatedfeedingstuff forrainbowtrouts

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

Marketingauthorisationholder:

IntervetInternationalB.V.

WimdeKörverstraat35

5831ANBoxmeer

TheNetherlands

Manufacturerforthebatchrelease:

ScheringPloughLtd.

BreakspearRoadSouth

Harefield,Uxbridge

UB96LS

UnitedKingdom

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Aquaflor500mg/gpremixformedicatedfeedingstuff forrainbowtrouts

Spain:FlorocolAqua500mg/gpremixformedicatedfeedingstuff forrainbowtrouts

Finland:Aquaflorvet500mg/gpremixformedicatedfeedingstuff forrainbowtrouts

Florfenicol

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

1gpremixcontains500mgflorfenicol.

Awhitefreeflowingpowder.

4. INDICATION(S)

ForthetreatmentandpreventionoffurunculosisinrainbowtroutcausedbyAeromonassalmonicida

susceptibletoflorfenicolinfreshwaterfisheries.Thepresenceofthediseaseshouldbeestablishedin

theholdingunitbeforeinitiatingthetreatment. Useoftheproductshouldbebasedonsusceptibility

testingofthebacteriaisolatedfromtheanimal.

5. CONTRAINDICATIONS

Donotuseinbroodstock.

Donotuseinanimalswithknownhypersensitivitytotheactiveingredient.

Donotadministertogetherwithotherantimicrobialproducts.

6. ADVERSEREACTIONS

None.Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinform

yourveterinarysurgeon.

7. TARGETSPECIES

Rainbowtrout(Oncorhynchusmykiss)

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

In-feeduse.Forthepreparationofmedicatedfeedingstuff.

Aquaflorpremixshouldbemixedintooronfeedtodeliveratotaldailydoserateof10mgof

florfenicolperkgbodyweightduring10consecutivedays.

Theentiredailyrationofmedicatedfeedshouldbeadministeredfirstforeachdayofthe10-day

dosingperiod.Ifthefeedingrateexceeds0.4%ofthebiomass,non-medicatedfeedmaybe

administeredafterthemedicatedration.Ifthefeedingrateis≤0.4%ofthebiomass,thenthedaily

rationshouldconsistofonlymedicatedfeedandbeadministeredatonetime.

Administrationofmedicatedfeedshouldbeginimmediatelyfollowingdiagnosistoensurethatfishare

abletoconsumethecompletemedicatedration.

Thisproductshouldbeincorporatedbylicensedfeedmanufacturersonly.Theconcentrationof

medicatedpremixinfeedshouldbeatleast≥0.5%or5kgpremix/tonfeed.

9. ADVICEONCORRECTADMINISTRATION

MixingInstructions:

Duringthepreparationofmedicatedfeed,thepremixiseithercoatedontothesurfaceofthepelletor

incorporatedintothefeedingredientmashpriortoextrusionorpelleting.

Top-coating:

Method1:Thedrypremixisthoroughlymixedwithfeedwhichtypicallycontains24–38%w/w

lipid.Approximately0.5%w/woilisthenaddedtothepremix/feedmixturetoimprovebothpremix

adhesionandpalatability.

a) Addknownquantityoffishfeedintoamixer.

b) Weighthepremix.

c) Mixpremixwithfeedpellets.

d) Medicatedfeedpelletsaremixed/coatedwithapredeterminedamountoffishorvegetableoil.

e) Atthecompletionofmixing,theproductistransferredtoastoragetankforpackagingor

transport.

Method2:Thedrypremixismixedwithoil.Thepremix/oilpreparationisthenaddedtothefeedto

producepalatablemedicatedfeedpellets.

e) Weighoutfishorvegetableoilintoabucket.

f) Weightoutthepremixandmixthoroughlywithoilinthebucket

g) Addaknownquantityoffishfeedintoamixer.

h) Addthepremixandoilmixturetothefeedinthemixer,slowly,whilethemixerisrunningat

lowspeed.Atthecompletionofmixing,theproductistransferredtoastoragetankfor

packagingortransport.

ExtrusionorPelleting:

Thedrypremixisaddeddirectlytothefeedingredientmashandmixedthoroughly.Waterandsteam

areadded,andthecompletemixtureisthenextrudedorpelleted,driedandpacked.

e) Thepremixisaddeddirectlytothefeedingredientmashandmixedthoroughlytoensure

homogeneity.

f) Themixtureissteampelletedandorextrudedandthepelletsaredried.

g) Medicatedfeedpelletsaremixed/coatedwithapre-determinedamountoffishorvegetableoil.

h) Atthecompletionofmixing,theproductistransferredtoastoragetankforpackagingor

transport.

RecommendedAquaflorpremixinclusionrateforpreparationofmedicatedfeed

FeedingRate AmountofAquaflor

PremixperMetric

TonneofFeed AmountofFlorfenicol

perFeedinmg/kg KilogramsofFishMedicatedper

MetricTonneofFeed(1000kg)for

10-dayTreatmentPeriod

%Biomass kg mg kg

0,4 5,0 2.500 25.000

0,3 6,7 3.333 33.333

0,2 10 5.000 50.000

Theformulaforcalculationoftheamountofpremixtobeaddedtofeedtoproducemedicatedfeedat

≥5kgpremix/tonfeedisasfollows:

20mgpremix(=10mgflorfenicol) Averagefishweight

perkgbodyweightandday x (kg) ═mgpremixperkgoffeed

Averagedailyfeedintake(kg/fish)

10. WITHDRAWALPERIOD

135degreedays

11. SPECIALSTORAGEPRECAUTIONS

Premix:Themedicinalproductdoesnotrequireanyspecialstorageconditions.

Storeinadryplace.

Keepseparatefromfeedsandfoodstuffs.

Medicatedfeed:Donotstoreattemperaturesabove25°C.

12. SPECIALWARNING(S)

Inordertomaximizefeeduptakethroughoutthepopulationtobetreated,medicatedfeedshouldbe

administeredfollowingthesamefeedingregimenaswasusedpriortotreatment,tothegreatestdegree

possible.Careshouldbetakenwhenadministeringmedicatedfeedbyhandthatfeedpelletsarewidely

dispersedtominimizehierarchicalfeedingbehaviour.

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromtheanimal.If

thisisnotpossible,therapyshouldbebasedonlocal(regional,farmlevel)epidemiological

informationaboutsusceptibilityofthetargetbacteria.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttoflorfenicol.Theproductshouldonlybeusedinfreshwaterfisheries. Benefit-risk

analysishasbeenconsideredfavorablewhentheproductisusedasindicatedforfurunculosisintrout

infreshwater.Benefitriskanalysishasnotbeenfullyperformedforuseinmarineaquaculture,

especiallywithregardstoenvironmentalrisk. Afullbenefit-riskanalysishasnotbeenperformedfor

useinmarineaquaculture..

Theuseoftheproductshouldalwaysbecombinedwithgoodmanagementpracticesofthefreshwater

fisheries(e.g.vaccinationprogrammes,biosecurity,waterqualityandsitehygiene).

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Weareitheradisposablehalf-maskrespiratorconformingtoEuropeanstandardEN149oranon-

disposablehalf-maskrespiratortoEuropeanStandardEN140withafiltertoEN143(locallyavailable

equivalenthalf-maskrespirator),chemicallyresistantgloves,protectivecoverallsandsafetyglasses

whileincorporatingthepremixintothefeed.

Wearglovesanddonotsmokeoreatwhilehandlingtheproductormedicatedfeed.Washhands

thoroughlywithsoapandwaterafteruseoftheproductormedicatedfeed.Thoroughlycleanall

equipmentusedinmedicatingfeed.

Incaseofaccidentalself-ingestionseekmedicaladviceimmediatelyandshowthelabeltothe

physician.

Peoplewithknownhypersensitivitytotheactiveingredientshouldavoidcontactwiththeveterinary

medicinalproduct.

Noadversereactionswereobservedaftertreatmentofrainbowtroutwith5timestherecommended

doseofflorfenicol.

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

DetailedinformationonthisproductisavailableonthewebsiteoftheEuropeanMedicinesAgency

(EMEA) http://www.emea.europa.eu /.

15. OTHERINFORMATION

2kgfoillaminatesachets.

Eight2kgsachetsarepackedinafibredrum.

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocalrepresentativeof

themarketingauthorisationholder.

16. EXPIRYDATE

EXP:

Onceopened,useby

17. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

18. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

19. MANUFACTURER´SBATCHNUMBER

BatchNo.

20. MARKETINGAUTHORISATIONNUMBER(S)

[Tobecompletednationally.]

23-11-2018

FDA Classifies Field Action Related to Fc 500™ And Epics® As Class 1 Recall Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions

FDA Classifies Field Action Related to Fc 500™ And Epics® As Class 1 Recall Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions

Beckman Coulter Life Sciences today announced the previously communicated global voluntary recall launched in January 2018 related to the FC 500™ Series Flow Cytometers (FC 500), COULTER® EPICS® XL™ and COULTER® EPICS® XL-MCL™ Flow Cytometer with System II Software (together referred to as the EPICS) has been classified as Class 1 by the U.S. Food and Drug Administration (FDA).

FDA - U.S. Food and Drug Administration

22-11-2018

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

Health Canada

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

1-10-2018

Public Notification: FX75000 contains hidden drug ingredient

Public Notification: FX75000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use FX75000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Black Rhino 25000 contains hidden drug ingredient

Public Notification: Black Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Black Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Krazzy Rhino 25000 contains hidden drug ingredient

Public Notification: Krazzy Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Krazzy Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Gold Rhino 25000 contains hidden drug ingredient

Public Notification: Gold Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Gold Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Platinum Rhino 25000 contains hidden drug ingredient

Public Notification: Platinum Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Platinum Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

26-6-2018

Huish Outdoors recalls Oceanic and Hollis Scuba Diving Regulators

Huish Outdoors recalls Oceanic and Hollis Scuba Diving Regulators

The scuba diving regulators can restrict airflow at low tank pressures (below 500 psi), posing a drowning hazard to divers.

Health Canada

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

20-6-2018

Public Notification: Black Stallion 35000 contains hidden drug ingredient

Public Notification: Black Stallion 35000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Black Stallion 35000, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

21-5-2018

Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor

Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Mini Cookies with Caramel Flavor”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

21-5-2018

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Liubitelskie Cookies”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

17-5-2018

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED).

FDA - U.S. Food and Drug Administration

18-4-2018

ViaGro 500mg Male Enhancement capsules

ViaGro 500mg Male Enhancement capsules

Safety advisory

Therapeutic Goods Administration - Australia

14-4-2018

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction.

FDA - U.S. Food and Drug Administration

28-3-2018

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Rhino 69 Extreme 50000, a product promoted and sold for sexual enhancement on various websites, including www.bonanza.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

25-9-2017

Global operation against illegal medicines

Global operation against illegal medicines

A global operation against illegal medicines has been completed. 123 countries participated, and the operation resulted in 354 arrests or further investigations and the suspension of more than 3,500 websites.

Danish Medicines Agency

20-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more:  https://go.usa.gov/xP

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xP

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn  #MedicalDevice #FDA pic.twitter.com/6e064UQ2wg

FDA - U.S. Food and Drug Administration