LFS Pyraclostrobin Pro

Primær information

  • Handelsnavn:
  • LFS Pyraclostrobin Pro Emulsionskoncentrat
  • Lægemiddelform:
  • Emulsionskoncentrat
  • Sammensætning:
  • 200 g/l pyraclostrobin
  • Brugt til:
  • Planter
  • Medicin typen:
  • agrokemiske

Dokumenter

  • for sundhedspersonale:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


    Anmode informationsbrochure for sundhedspersonale.

Lokation

  • Fås i:
  • LFS Pyraclostrobin Pro Emulsionskoncentrat
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • SEGES Landbrug & Fødevarer
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • Må ikke anvendes nærmere end 10 meter fra vandmiljøet (vandløb, søer m.v.) for at beskytte organismer, der lever i vand.
  • Sidste ændring:
  • 23-07-2018

Indlægsseddel

LFS Pyraclostrobin Pro

Svampemiddel

Må kun anvendes til bekæmpelse af svampesygdomme i korn, frøgræs og majs.

Gældende fra 26. november 2015:

Dette plantebeskyttelsesmiddel må kun købes af professionelle og anvendes

erhvervsmæssigt og kræver gyldig autorisation.

Omfattet af Miljøministeriets bekendtgørelse om bekæmpelsesmidler og

plantebeskyttelsesmiddelforordningen 1107/2009

Svampemiddel nr. 318-198

Analyse:

Pyraclostrobin 200 g/L

(19,2% w/w )

Midlet indeholder solvent naphta (råolie), tung aromatisk

Indhold:

liter - Midlet er et emulsionskoncentrat

Godkendelsesindehaver:

v/20 C

o

5

LFS Kemi

Navervej 4

6600 Vejen

Fare

EUH401 Brugsanvisningen skal følges for ikke at

bringe menneskers sundhed og miljøet i fare.

Må kun anvendes til

bekæmpelse af

svampe-

sygdomme i korn, frøgræs og majs.

Må ikke anvendes mod andre skadevoldere og

ikke i

højere doseringer end de i

brugsanvis-

ningen nævnte.

Må ikke anvendes senere end 35 dage før høst i

hvede, og må ikke anvendes senere end 42 dage

før høst i rug, triticale, byg og havre. Må i majs

ikke anvendes senere end i vækststadium 65. Må i

frøgræs kun anvendes i vækststadium 30-69, og

halm fra høstet

frøgræs

må ikke

bruges

til

opfodring.

Må ikke anvendes nærmere end 10

meter fra vandmiljøet (vandløb, søer m.v.) for at

beskytte organismer,

der lever i

vand.

Undgå

forurening af

vandmiljøetmed produktet

eller med

beholdere,

der har indeholdt

produktet.

P405+P102 Opbevares under lås og utilgængeligt for

børn.

Må ikke opbevares sammen med fødevarer,

drikke-

varer og foderstoffer.

H319 Forårsager alvorlig øjenirritation.

H315 Forårsager hudirritation.

H332 Farlig ved indånding.

H302 Farlig ved indtagelse.

H317 Kan forårsage allergisk hudreaktion.

H304 Kan være livsfarligt,

hvis det

indtages og

kommer i luftvejene.

H410 Meget

giftig med langvarige virkninger for

vandlevende organismer.

Vær opmærksom på, at Arbejdstilsynet har regler for

arbejde

udsættelse

forplantebeskyttel-

sesmidler. Læs nærmere i det eventuelt lovpligtige

sikkerhedsdatablad.

Rens

ikke

sprøjteudstyr nær overfladevand.

Overtrædelse af nedenstående særligt fremhævede

forskrifter kan medføre straf:

Førstehjælpsforanstaltninger:

P101 Hvis

brug for

lægehjælp,

medbring da

beholderen eller etiketten.

P301+P310+P331 I TILFÆLDEAF INDTAGELSE:

Ring omgående til en GIFTINFORMATION eller en læge.

Fremkald IKKE opkastning.

P330 Skyl munden

P304+P340 VED INDÅNDING: Flyt personen til et sted

med frisk luft og sørg for, at vejrtrækningen lettes.

P305+P351+P338 VED KONTAKT MED ØJNENE: Skyl

forsigtigt

med vand i

flere minutter.

Fjerne eventuellte

kontaktlinser, hvis dette kan gøres let. Fortsæt skylning.

P337+P313 Ved vedvarende øjenirritation: Søg lægehjælp.

P302+P352 VED KONTAKT MED HUDEN: Vask med

rigeligt sæbe og vand.

P333+P313 Ved hudirritation eller udslæt: Søg lægehjælp.

P312 I tilfælde af ubehag ring til en GIFTINFORMATION

eller en læge.

P362 Forurenet tøj tages af og vaskes, før det bruges igen.

Vigtigste symptomer og virkninger, både akutte og forsinkede.

Angivelse af

om øjeblikkelig lægehjælp og særlig be-handling

er nødvendig.

Nødsituation: Giftlinjen, tlf. 82 12 12 12 (døgntelefon)

Symptomer:

De vigtigste kendte symptomer

og virkninger

beskrevet i mærkningen af produktst (se afsnit 2 i sds) og/eller i

afsnit

Yderligere vigtige symptomer og virkninger er indtil

videre ikke kendte.

Behandling:

Symptomatisk

behandling

(dekontamination,

vitalfunktionen), ingen specifik modgift kendes.

P280 Bær beskyttelseshandsker /øjenbeskyttelse.

P261 Undgå indånding af dampe/spray.

P270 Der må ikke spises, drikkes eller ryges under

brugen af dette produkt.

Batch nr.: Se emballagen

Udløbsdato: Se emballagen

BRUGSANVISNING

Virknings mekanisme:

Effekter:

Anvendelse:

Resistens:

Blanding:

Sprøjteteknik:

Tilberedning af sprøjtevæske:

Præparatfyldeudstyr

Direkte injektion

Rengøring:

Tom emballage:

Lagring:

Pyraclostrobin tilhører gruppen af strobiluriner, som virker ved at blokere for

elektrontransporten i

mitokondrierne hvorved svampens ånding og energi

opbygning påvirkes. Ved forebyggende behandlinger forhindres infektion på

tidligst

mulige

tidspunkt;

når

svampesporerne

spirer

bladet.

behandling efter infektion hæmmes svampens videre udbredelse i bladet.

Pyraclostrobin absorberes meget hurtigt i vokslaget efter udsprøjtningen. Det

aktive stof frigives, fordeles og absorberes løbende på og i plantevævet. Det

giver

en lang virkningstid og en ensartet

effektiv beskyttelse

hele

bladmassen på såvel over- som undersiden af bladene.

LFS Pyraclostrobin Pro har effekt mod en lang række sygdomme i korn (se

tabel), desuden kan en behandling med

i nogle tilfælde

have en positiv indflydelse på udbyttet

og/eller kvaliteten af den høstede

afgrøde, selv om der ikke er synlige angreb af svampesygdomme

* = svag effekt ***** = special middel

I frøgræs har

god effekt overfor kronrust i rajgræs,

dreschlera bladplet i svingel, mastigosporium bladplet i hundegræs samt

rust i engrapgræs.

I majs har

god effekt overfor majs bladplet

(Helminto-sporium turcicum) og majs øjeplet (Kabatiella zea).

Korn:

kan anvendes

fra begyndende strækningsvækst

vækststadium 30 og indtil

begyndende kernedannelse vækststadium 69 i

hvede, byg, rug, triticale og havre.

optages hurtigt i bladene og er regnfast efter indtørring

sprøjtevæsken.

Vær

opmærksom på om eventuelle blandingspartnere

kræver en længere periode for at være regnfast.

Virkningen af

en behandling med 1,25 l/ha

strækningsfasen vil

være 3 –5 uger afhængig af smittetryk,

de klimatiske

forhold,

sortens modtagelighed,

udvikling af

symptomer

samt

afgrødens

tilvæksthastighed.

bør altid tankblandes med et kornfungicid med en

anden virkningsmekanisme som er

effektiv mod de

relevante svampe-

sygdomme f.eks.

Bell.

Anvend strobilurinholdige produkter forebyggende

eller så tidligt som muligt i infektionsforløbet.

Frøgræs:

Der er ikke konstateret skader på afgrøderne som følge af sprøjtning med LFS

Pyraclostrobin Pro, men svampemidler herunder

bør

ikke udbringes under meget tørre og varme forhold med kraftig sol indstråling.

Undgå at sprøjte på en stresset afgrøde f.eks. som følge af tørke eller en ukrudts

sprøjtning.

mange

fungicider

risiko for

forekomst

biotyper,

modstandsdygtige (resistente) overfor de anvendte aktivstoffer.

(pyraclostrobin)

tilhører

gruppen af

strobiluriner

(FRAC gruppe 11),

som vurderes at

have en høj

risiko for

udvikling af

resistens.

Danmark er

fundet

resistens

overfor

hvedens

gråplet,

hvedebladplet,

meldug og ramularia i

korn.

Gentagne behandlinger

midler med samme virkemekanisme øger risikoen for udvikling af resistens.

For at undgå udvikling af resistens må dette produkt eller andre produkter, der

indeholder pyraclostrobin, ikke anvendes mere end 2 gange per sæson, i byg

dog kun 1 gang per sæson.

For at mindske risikoen for udvikling af resistens anbefales det at blande med

eller skifte mellem midler med andre virkemekanismer, som har god effekt

over for de aktuelle arter.

Risikoen for resistens hos fungicider kan nedsættes ved sprøjtning tidligt i

infektionsforløbet.

kan blandes med Bell,

Opus,

Opera,

Juventus 90,

Flexity,

Ceando,

Fastac 50,

Medax Top,

Cycocel

750 og Terpal.

hovedregel tilsættes blandingspartneren til sidst.

Det er altid vigtigt at følge vejledningen på blandingspartnerens etikette. Alle

tankblandinger udsprøjtes straks.

skal

udbringes med en marksprøjte (eller

anden

sprøjte), som er kalibreret og lever op til de standarder og specifikationer, som

er givet af sprøjteproducenten. Ved påfyldning af marksprøjte skal anvendes

præparatfyldeudstyr eller udstyr til direkte injektion.

Udbringning skal

altid tilpasses afgrødens udvikling mht.

højde,

tæthed,

fugtighed, ol.

Udbringning af sprøjtemidler skal til hver en tid ske på en sådan måde,

overlapning i marken samt spild uden for området begrænses til et minimum,

og at afdrift til omgivelserne undgås.

Vindhastigheden skal altid være lav (< 4 m/s) på behandlingstidspunktet, og

low-drift dyser bør så vidt muligt anvendes, for yderligere at reducere risikoen

for afdrift.

Valg af dyse tilpasses opgaven og der findes en lang række fabrikater på

markedet, der opfylder gældende regler. Nedenstående angiver eksempler på

mulige dyser.

Sørg altid for at sprøjten er korrekt rengjort samt efterset for belægninger inden

tilberedning af sprøjtevæsken begyndes. Dette gælder især, hvis sprøjten har

været anvendt til sprøjteopgaver i andre afgrøder.

Ved anvendelse af præparatfyldeudstyr og flydende præparater påyldes den

ønskede mængde præparat, som herefter suges op i sprøjtetanken.

Efterføgende skyldes præparatfyldeudstyret,

samt

tomme dunke/beholdere.

Gentag proceduren med at åbne/lukke for bundventil til der ikke er synlige

spor af

i fyldestationen.

Additiv/penetreringsolier tilsættes til sidst inden den endelige tankblanding er

udført.

Ved anvendelse af direkte injektionsudstyr,

ledes det ufortyndede præparat

automatisk ind i de slanger, som fører fra sprøjtetank til dyserne. Ved skift og

afslutning af sprøjteopgaver gennemføres en gennemskylning og rengøring af

systemet. Vaskevandet udsprøjtes under kørsel på det behandlede areal.

Generelt

bør der være konstant

omrøring under udbringning og kørsel

sprøjteæsken udsprøjtes straks efter tilberedningen.

Efter endt sprøjtearbejde skal sprøjten og traktor rengøres enten i marken eller

på vaskepladsen.

En uvasket sprøjte skal placeres i den behandlede mark, på vaskepladsen eller

under tag.

Sprøjten skal være monteret med spuledyser til indvendig rengæring af tanken

og sprøjten skal

være monteret

med separat

vandtank med tilstrækkelig

kapacitet således at restsprøjtevæske kan fortyndes og der kan foretages en

grundig rengøring i marken. Restsprøjtevæske skal på passende vis fortyndes

50 gange med vand og udsprøjtes i

den behandlede mark (uden at

maksimalt tilladte dosering for det pågældende middel herved overskrides).

Rengøring i øvrigt foretages med egnede rengøringsmidler (se evt. etiketten på

det sidst anvendte middel for specifikke anvisninger) samtidig med at filtre,

slanger

og dyser

kontrolleres

urenheder

og eventuelle belægninger.

Vaskevandet opsamles i egnede beholdere og udbringes iht. gældende regler.

I øvrigt henvises til Miljøministeriets vejledning om påfyldning og vask af

sprøjter

udbringning

bekæmpelsesmidler,

Miljøministeriets

bekendtgørelse nr. 1355 af 14. december 2013. P391 Udslip opsamles.

Rester skal

afleveres til

den kommunale affaldsordning for farligt

affald.

Tomme beholdere kan bortskaffes med dagrenovationen. Den tomme beholder

bør skylles inden bortskaffelse.

Skyllevandet hældes op i sprøjtevæsken. Emballagen må ikke genbruges.

P501 Indholdet/beholderen bortskaffes i overensstemmelse med kommunale

regler for affaldshåndtering.

LFS Pyraclostrobin Pro bør

opbevres frostfrit

uåbnet

originalemballage

beskyttet mod direkte sollys og andre varmekilder og ikke over 40 C.

korrekt

opbevaring er

produktet

holdbart

minimum 2 år

fra fabrika-

tionsdatoen.

--------------------------------------------------------

Producenten fralægger sig ethvert ansvar for produktets effekt samt skader,

herunder følgeskader, der er opstået gennem ikke forskriftsmæssig opbevaring

og/eller anvendelse af produktet.

LFS Pyraclostrobin Pro

LFS Pyraclostrobin Pro

LFS Pyraclostrobin Pro

LFS Pyraclostrobin Pro

LFS Pyraclostrobin Pro

LFS Pyraclostrobin Pro

LFS Pyraclostrobin Pro

Pyraclostrobin

anvendes

vækststadium 30-69

svampesygdomme i frøgræs.

LFS Pyraclostrobin Pro har alene god effekt

mod en række sygdomme i

frøgræs, og ofte vil

1 behandling med halv til hel dosis være tilstrækkeligt. En

bredere effekt

kan opnås ved blanding med Bell.

Ved blanding med Bell

mindskes risikoen for resistensopbygning tilligemed.

Majs:

Pyraclostrobin

anvendes

vækststadium 30-65

svampesygdomme i majs.

LFS Pyraclostrobin Pro

LFS Pyraclostrobin Pro

LFS Pyraclostrobin Pro

LFS Pyraclostrobin Pro

LFS Pyraclostrobin Pro

Skadegører

Effekt

*

**

****

****

Skadegører

Effekt

Hvedemeldug

Bygmeldug

Gulrust

Brunrust

Bygrust

****(*)

Septoria

Hvedebladplet (DTR)

Skoldplet

***(*)

Bygbladplet

****(*)

Ramularia

(Kilde: Landsoversigten s. 89 2013 effekter fra Comet)

Effekterne på meldug (hvede og byg), hvedegråplet, hvedebrunplet, hvedebladplet og

ramularia i byg må pga. resistens forventes at være svage.

Afgrøde

Skadevolder

Dosering pr. ha

Tidspunkt

Bemækninger

Hvede (vinter

Gulrust

0,6-1,25 l

30-69

Maks. 2 x 1,25 l/ha

og vår)

Brunrust

pr. sæson

Sprøjtefrist 35 dage

Byg (vinter

Bygrust

0,6-1,25 l

30-59

Maks 1 x 1,25 l/ha

og vår

Bygbladplet

pr. sæson

Skoldplet

Sprøjtefrist 42 dage

Havre

Kronrust

0,6-1,25 l

30-59

Maks. 2 x 1,25 l/ha

pr. sæson

Sprøjtefrist 42 dage

Vinterrug

Brunrust

0,6-1,25 l

30-59

Maks. 2 x 1,25 l/ha

Skoldplet

pr. sæson

Sprøjtefrist 42 dage

Triticale

Gulrust

0,6-1,25 l

30-59

Maks. 2 x 1,25 l/ha

Brunrust

pr. sæson

Sprøjtefrist 35 dage

3 bar tryk

Ydelse (l/min)

Hastighed (km/t)

Væskemængde pr. ha

ISO LD 0,15(grøn) 0,6

ISO LD 0,2 (gul)

Afgrøde

Skadevolder

Dosering pr. ha

Tidspunkt

Bemærkninger

Rajgræs (Alm. Kronrust, plet- 0,6-1,25 l

30-69

Maks. 2 x 1,25 l/ha

og ital.)

og netnekrose

pr. sæson

Ikke senere end

vækstst. 69

Hundegræs

Skoldplet og

0,6-1,25 l

30-69

Maks. 2 x 1,25 l/ha

mastigospo

pr. sæson

rium bladplet

Ikke senere end

vækstst. 69

Rødsvingel

Rust

0,6-1,25 l

30-69

Maks. 2 x 1,25 l/ha

Strandsvingel

Dreschlera

pr. sæson

Stivbladet

bladplet

Ikke senere end

svingel

vækstst. 69

Engsvingel

Engrapgræs

Rust

0,6-1,25 l

30-69

Maks. 2 x 1,25 l/ha

pr. sæson

Ikke senere end

vækstst. 69

Afgrøde

Skadevolder

Dosering pr. ha

Tidspunkt

Bemærkninger

Majs

0,5-1,0 l

30-65

Maks. 1 l/ha pr. sæson

Majs bladplet

solo eller i splitbe-

Majs øjeplet

handling.

Ikke senere end

vækstst. 65

God effekt på:

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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

Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk

Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk

Johnston County Hams’ country ham was recalled due to its potential for contamination with Listeria monocytogenes; therefore, Ukrop’s made the decision that any products that contained country ham or came into contact with equipment used to process the country ham are being recalled due to the potential to be contaminated with Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

9-10-2018

Essity Professional Hygiene North America LLC recalls Tork Foam Soap Extra Mild SKU

Essity Professional Hygiene North America LLC recalls Tork Foam Soap Extra Mild SKU

The recalled product is potentially contaminated with the bacteria Burkholderia cepacia. B. cepacia is found in soil and water and poses little medical risk to healthy people.

Health Canada

6-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

5-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

5-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

4-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Shengan Natural Model contains hidden drug ingredient

Public Notification: Shengan Natural Model contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Shengan Natural Model, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: USA for Women contains hidden drug ingredient

Public Notification: USA for Women contains hidden drug ingredient

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

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: In Shape contains hidden drug ingredient

Public Notification: In Shape contains hidden drug ingredient

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

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: ProSolution contains hidden drug ingredient

Public Notification: ProSolution contains hidden drug ingredient

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Pro Solution, 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

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

1-10-2018

Public Notification: Baschi Quick Slimming Capsule contains hidden drug ingredients

Public Notification: Baschi Quick Slimming Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Baschi Quick Slimming Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: V-Max contains hidden drug ingredient

Public Notification: V-Max contains hidden drug ingredient

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

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Strong Horses contains hidden drug ingredient

Public Notification: Strong Horses contains hidden drug ingredient

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

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Green Lean Body Capsule contains hidden drug ingredients

Public Notification: Green Lean Body Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Green Lean Body Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Like Slim Coffee contains hidden drug ingredient

Public Notification: Like Slim Coffee contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Like Slim Coffee, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

28-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

28-9-2018

Drug agency from China visits Denmark

Drug agency from China visits Denmark

A delegation from the Centre for Drug Evaluation under the China National Medical Products Administration visited the Danish Medicines Agency this week to discuss clinical trials and drug monitoring, among other things. The meeting at the Danish Medicines Agency is part of a Danish-Chinese collaboration under the auspices of the China-Denmark Food and Drug Regulatory Cooperation Centre, which was established with the signing of a collaboration agreement in May of last year, and which aims to strengthen r...

Danish Medicines Agency

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

27-9-2018

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

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

FDA - U.S. Food and Drug Administration

25-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

25-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

2-10-2018

Zavesca (Janssen-Cilag International NV)

Zavesca (Janssen-Cilag International NV)

Zavesca (Active substance: Miglustat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5472 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000435/T/0063

Europe -DG Health and Food Safety

2-10-2018

Dynastat (Pfizer Europe MA EEIG)

Dynastat (Pfizer Europe MA EEIG)

Dynastat (Active substance: Parecoxib ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6471 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000381/T/0073

Europe -DG Health and Food Safety

2-10-2018

Retacrit (Pfizer Europe MA EEIG)

Retacrit (Pfizer Europe MA EEIG)

Retacrit (Active substance: epoetin zeta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6481 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/872/T/86

Europe -DG Health and Food Safety

2-10-2018

HALAVEN (Eisai GmbH)

HALAVEN (Eisai GmbH)

HALAVEN (Active substance: eribulin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6457 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2084/T/46

Europe -DG Health and Food Safety

2-10-2018

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14

Europe -DG Health and Food Safety

2-10-2018

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Active substance: esomeprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6474 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002618/T/0023

Europe -DG Health and Food Safety

1-10-2018

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Active substance: Mycoplasma synoviae Strain MS-H live attenuated thermosensitive) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6404 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/161/T/11

Europe -DG Health and Food Safety

1-10-2018

Verzenios (Eli Lilly Nederland B.V.)

Verzenios (Eli Lilly Nederland B.V.)

Verzenios (Active substance: abemaciclib) - Centralised - Authorisation - Commission Decision (2018)6405 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4302

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Active substance: Icatibant acetate) - Transfer of orphan designation - Commission Decision (2018)6432 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/054/02/T/01

Europe -DG Health and Food Safety

1-10-2018

Gefitinib Mylan (Mylan S.A.S.)

Gefitinib Mylan (Mylan S.A.S.)

Gefitinib Mylan (Active substance: gefitinib) - Centralised - Authorisation - Commission Decision (2018)6406 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4826

Europe -DG Health and Food Safety

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

26-9-2018

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Active substance: pimobendan / benazepril) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6321 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2804/T/11

Europe -DG Health and Food Safety

26-9-2018

Comfortis (Elanco GmbH)

Comfortis (Elanco GmbH)

Comfortis (Active substance: Spinosad) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6323 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2233/T/18

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

25-9-2018

Udenyca (ERA Consulting GmbH)

Udenyca (ERA Consulting GmbH)

Udenyca (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6290 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004413/0000

Europe -DG Health and Food Safety

25-9-2018

Inovelon (Eisai GmbH)

Inovelon (Eisai GmbH)

Inovelon (Active substance: Rufinamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6283 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/660/T/48

Europe -DG Health and Food Safety

25-9-2018

Zonegran (Eisai GmbH)

Zonegran (Eisai GmbH)

Zonegran (Active substance: zonisamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6285 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/577/T/90

Europe -DG Health and Food Safety

25-9-2018

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (Active substance: melatonin) - Centralised - Authorisation - Commission Decision (2018)6223 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425

Europe -DG Health and Food Safety

25-9-2018

Brilique (AstraZeneca AB)

Brilique (AstraZeneca AB)

Brilique (Active substance: ticagrelor) - PSUSA - Modification - Commission Decision (2018)6282 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1241/PSUSA/2948/201712

Europe -DG Health and Food Safety

25-9-2018

Fycompa (Eisai GmbH)

Fycompa (Eisai GmbH)

Fycompa (Active substance: Perampanel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6280 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002434/T/0040

Europe -DG Health and Food Safety

25-9-2018

Opsumit (Janssen-Cilag International NV)

Opsumit (Janssen-Cilag International NV)

Opsumit (Active substance: macitentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6279 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002697/T/0028

Europe -DG Health and Food Safety

25-9-2018

Imfinzi (AstraZeneca AB)

Imfinzi (AstraZeneca AB)

Imfinzi (Active substance: durvalumab) - Centralised - Authorisation - Commission Decision (2018)6289 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004771/0000

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety