Enroxil Flavour Tablets 50 mg

Main information

  • Trade name:
  • Enroxil Flavour Tablets 50 mg
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Enroxil Flavour Tablets 50 mg
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • enrofloxacin
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0255/002
  • Authorization date:
  • 12-10-2009
  • EU code:
  • UK/V/0255/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:December2009

AN:01103/2009

SUMMARYOFPTODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

EnroxilFlavour50mgTabletsfordogs

EnroxFlavour50mgTabletsfordogs(UnitedKingdom,Austria,Belgium,

Germany,Denmark,Greece,Ireland,Italy,Luxembourg,Netherlands)

EnroxSabor50mgTabletsfordogs(Spain,Portugal)

EnroxilFlavour50mgTabletsfordogs(Bulgaria,CzechRepublic,Hungary,

Lithuania,Latvia,Poland,Romania,Slovenia,Slovakia)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Eachtabletcontains:

Enrofloxacin50mg

Excipients:Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet.

Roundslightlybiconvex,creamtolightbrownishtabletswithpossiblevisible

whiteordarkerspots,onesidescoredandbevel-edged.Thetabletscanbe

dividedintoequalhalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Theproductisforuseindogsforthetreatmentofbacterialinfectionsofthe

alimentary,respiratoryandurogenitaltracts,skin,secondarywoundinfections

andotitisexternawhereclinicalexperience,supportedwherepossibleby

sensitivitytestingofthecausalorganism,indicatesenrofloxacinasthedrugof

choice.

4.3 Contraindications

Donotuseindogslessthan1yearofageorinexceptionallylargebreedsof

dogwithalongergrowthperiodlessthan18monthsofage,asarticular

cartilagemaybeaffectedduringtheperiodofrapidgrowth.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

Donotuseindogshavingseizuredisorders,sinceenrofloxacinmaycause

CNSstimulation.

Revised:December2009

AN:01103/2009

4.4 Specialwarningsforeachtargetspecies

Pleaseseepoint4.3.

4.5 Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditions

whichhaverespondedpoorly,orareexpectedtorespondpoorlytoother

classesofantimicrobials.Wheneverpossible,useoffluoroquinolonesshould

bebasedonsusceptibilitytesting.Useoftheproductdeviatingfromthe

instructionsgivenintheSPCmayincreasetheprevalenceofbacteria

resistanttothefluoroquinolonesandmaydecreasetheeffectivenessof

treatmentwithotherquinolonesduetothepotentialforcross-resistance.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

productisused.

Donotexceedtherecommendeddosage.

Theproductshouldnotbeusedforprophylaxis.

Usetheproductwithcautionindogswithsevererenalorhepaticimpairment.

ii) Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteruse.

Incaseofcontactwiththeeyes,washwithplentyofcleanwater.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshow

thepackageleaflettothephysician..

Peoplewithknownhypersensitivitytofluoroquinolonesshouldavoidcontact

withtheproduct.

4.6Adversereactions(frequencyandseriousness)

Duringtheperiodofrapidgrowth,enrofloxacinmayaffectarticularcartilage

development.

Inrarecasesvomitingandanorexiaareobserved

4.7Useduringpregnancy,lactationorlay

Useonlyaccordingtothebenefit:riskassessmentbytheveterinarysurgeon.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Donotcombinewithtetracyclines,phenicolsormacrolidesbecauseof

potentialantagonisticeffects.

Concurrentadministrationoffluoroquinolonesmayincreasetheactionoforal

anticoagulants.

Donotcombinewiththeophyllineasthiscouldleadtoaprolongedelimination

ofthissubstance.

Revised:December2009

AN:01103/2009

Concurrentadministrationofmagnesiumoraluminumcontainingsubstances

maybefollowedbyretardedabsorptionofenrofloxacin.

4.9 Amountstobeadministeredandadministrationroute

Donotexceedtherecommendeddose.Thedosagerateofenrofloxacinis5

mg/kggivenorallyoncedailyorasadivideddosetwicedailyfor5to10days

withorwithoutfood.

Thedurationoftreatmentindogsmaybeextendeddependingontheclinical

responseandthejudgementoftheresponsibleveterinarysurgeon.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccurately

aspossibletoavoidunderdosing.

Thedailydoseisachievedasfollows:

Mediumdogs:onetabletper10kgbodyweight.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inaccidentaloverdosevomiting,diarrhoeaandCNS/behaviouralchanges

mayoccur.Thereisnoantidoteandtreatmentshouldbesymptomatic.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Enrofloxacinisasynthetic,broadspectrum

antimicrobialsubstance,belongingtothefluoroquinolonegroupofantibiotics.

ATCvetcode:QJ01MA90

5.1 Pharmacodynamicproperties

EnrofloxacinisbactericidalinactionwithactivityagainstGrampositiveand

Gramnegativebacteriaandmycoplasmas.Themechanismofactionofthe

quinolonesisuniqueamongantimicrobials –theyactprimarilytoinhibit

bacterialDNAgyrase,anenzymeresponsibleforcontrollingthesupercoiling

ofbacterialDNAduringreplication.Resealingofthedoublestandardhelixis

inhibitedresultinginirreversibledegradationofthechromosomalDNA.The

fluoroquinolonesalsopossessactivityagainstbacteriainthestationaryphase

byanalterationofthepermeabilityoftheouthermembranephospholipidcell

wall.

Bacterialresistancetofluoroquinolonesmostcommonlyoccursbyalterationof

thetarget,DNA-gyrase,viamutation.Lesscommonlymutationoccursatthe

topoisomerase-IVtarget.Othermechanismsofresistanceoccurwhen

bacteriadecreasetheabilityofthedrugtoenterthecellorincreaseactive

transportoutofthecell.Resistanceisusuallychromosomallydevelopedand,

therefore,remainsafterantimicrobialtherapyends.Cross-resistanceof

enrofloxacinwithotherfluoroquinolonescanoccur.Changesinlevelsof

resistancetofluoroquinolonesovertimebyCampylobacterandSalmonella

Revised:December2009

AN:01103/2009

speciesarebeingmonitoredbecauseoftheirpossibleimpactonhuman

health.

5.2 Pharmacokineticparticulars

Thepharmacokineticsofenrofloxacinindogsissuchthatoralandparenteral

administrationleadstosimilarserumlevels.

Enrofloxacinisrapidlyabsorbedafteroral,intramuscularandsubcutaneous

administration.

Inthestudyconductedindogsthedoseofenrofloxacinadministeredwas4.91

mg/kg.Themaximalplasmaconcentrationwas1179.94±260,83ng/mL,Tmax

was1.57±0.62h,halflife3,78h(harmonicmean)andAUC

tot value

4037±1155.82ngh/mL.

Approximately40%oftheoralorintravenousenrofloxacindoseadministered

indogsismetabolisedtociprofloxacin.

Themeanmaximalconcentrationforciprofloxacinreached491.99±57.95

ng/mL,tmax1.79±2.6handtheapparentterminalhalflifewas5.10h

(harmonicmean).ThemeanAUC

tot forciprofloxacinwas3737.21±562.65

ngh/mL.

Enrofloxacinpossessesahighdistributionvolume.Tissuelevels2-3times

higherthanthatfoundintheserum,havebeendemonstratedinlaboratory

animalsandtargetspecies.Organsinwhichhighlevelscanbeexpectedare

thelungs,liver,kidney,skin,boneandlymphaticsystem.Enrofloxacinalso

distributesintothecerobrospinalfluid,theaqueoushumourandthefoetusin

pregnantanimals.

Theeliminationofenrofloxacinisrenal,primarilythroughglomerularfiltration

andtubularsecretion.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Mannitol

Maizestarch

Sodiumstarchglycolate(typeA)

Meatflavour10022

Sodiumlaurilsulphate

Basicbutylatedmethacrylatecopolymer

Dibutylsebacate

Croscarmellosesodium

Silica,colloidalanhydrous

Talc

Magnesiumstearate

6.2Incompatibilities

Noneknown.

Revised:December2009

AN:01103/2009

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Returnanyhalvedtablettotheopenedstrip-packandusewithin24hours.

6.4Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorage

conditions.

6.5Natureandcompositionofimmediatepackaging

Polyamide/Aluminium/Polyvinylchloridefilm(OPA/Al/PVC),heatsealedwith

aluminiumfoilcontaining10tablets/blister.Eachcardboardcartoncontains

10blisterpacks.

Polyamide/Aluminium/Polyvinylchloridefilm(OPA/Al/PVC),heatsealedwith

aluminiumfoilcontaining10tablets/blister.Eachcardboardcartoncontains

1blisterpacks.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

Telephonenumber:073312111

Faxnumber:073321537

Email:info@krka.biz

8. MARKETINGAUTHORISATIONNUMBER

Vm 01656/4008

9. DATEOFFIRSTAUTHORISATION

18June2009

10. DATEOFREVISIONOFTHETEXT

December2009

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Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

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

7-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

31-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

22-8-2018

Germany Niubian tablets

Germany Niubian tablets

Germany Niubian tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

22-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

18-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

15-8-2018

G Female Oral Tablets

G Female Oral Tablets

G Female Oral Tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

25-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

28-6-2018

Need for Seal tablets

Need for Seal tablets

Need for Seal tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

28-6-2018

Gold Maka tablets

Gold Maka tablets

Gold Maka tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

28-6-2018

One Night Lover tablets

One Night Lover tablets

One Night Lover tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

19-6-2018

Bulbao Male Enhancer tablets

Bulbao Male Enhancer tablets

Bulbao Male Enhancer tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

19-6-2018

Meltz – Instant Energy For Males tablets

Meltz – Instant Energy For Males tablets

Meltz Instant Energy For Males tablets pose a serious risk to your health and should not be taken.

Therapeutic Goods Administration - Australia

5-6-2018

Valpam 5 (diazepam) 5 mg tablets

Valpam 5 (diazepam) 5 mg tablets

Product defect alert - potential for blister strip to contain lower strength tablets

Therapeutic Goods Administration - Australia

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

10-4-2018

Stree Overlord Strong tablets (pills)

Stree Overlord Strong tablets (pills)

Safety alert - stree overlord tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

9-4-2018

Black Ant King tablets

Black Ant King tablets

Safety advisory

Therapeutic Goods Administration - Australia

6-4-2018

Two lots of the epilepsy drug Primidone recalled because of high levels of lead, which may pose serious health risks

Two lots of the epilepsy drug Primidone recalled because of high levels of lead, which may pose serious health risks

Health Canada is advising Canadians that AA Pharma Inc. is voluntarily recalling two lots of Primidone tablets because they contain high levels of lead. The company has indicated that only the lots identified below are affected by this issue.

Health Canada

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety

4-6-2018

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Active substance: apixaban) - Centralised - 2-Monthly update - Commission Decision (2018)3616 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2148/II/50

Europe -DG Health and Food Safety