产品召回行业指南

OnFebruary2,2024,FDApublishedthefinalruletoamendtheQualitySystem(QS)regulation

in21CFRpart820(89FR7496,effectiveFebruary2,2026).Therevised21CFRpart820is

nowtitledtheQualityManagementSystemRegulation(QMSR).TheQMSRharmonizesqualitymanagementsystemrequirementsbyincorporatingbyreferencetheinternationalstandard

specificformedicaldevicequalitymanagementsystemssetbytheInternationalOrganizationforStandardization(ISO),ISO13485:2016.TheFDAhasdeterminedthattherequirementsinISO13485are,whentakenintotality,substantiallysimilartotherequirementsoftheQSregulation,providingasimilarlevelofassuranceinafirm’squalitymanagementsystemandabilityto

consistentlymanufacturedevicesthataresafeandeffectiveandotherwiseincompliancewiththeFederalFood,Drug,andCosmeticAct(FD&CAct).

ThisguidancedocumentwasissuedpriortothefinalruleissuedonFebruary2,2024.Whilethisguidancediscussesrecallproceduresandrequirements,manufacturersshouldbeawarethattheQMSRincludesupdatedqualitymanagementsystemrequirementsthatmayimpactrecall-relatedprocessesformedicaldevicesorcombinationproducts.

FDAencouragesmanufacturerstoreviewthecurrentQMSRtoensurecompliancewiththerelevantregulatoryrequirements.

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ProductRecalls,IncludingRemovals

andCorrections

GuidanceforIndustry

TheFDAisissuingthisguidanceforimmediateimplementationinaccordancewith21CFR

10.115(g)(4)(i).Submitonesetofeitherelectronicorwrittencommentsonthisguidanceatanytime.Submitelectroniccommentsto

/

.SubmitwrittencommentstotheDocketsManagementStaff,FoodandDrugAdministration,5630FishersLane,Room

1061,Rockville,MD20852.AllcommentsshouldbeidentifiedwiththedocketnumberFDA-2003-D-0146.

Forquestionsregardingthisguidanceoradditionalcopies,contacttheOfficeofRegulatoryAffairs(ORA)OfficeofStrategicPlanningandOperationalPolicy(OSPOP)at

ORAPolicyStaffs@

U.S.DepartmentofHealthandHumanServices

FoodandDrugAdministration

OfficeofRegulatoryAffairs

CenterforDevicesandRadiologicHealth

CenterforBiologicsEvaluationandResearch

CenterforDrugEvaluationandResearch

CenterforFoodSafetyandAppliedNutrition

CenterforTobaccoProducts

CenterforVeterinaryMedicine

MARCH2020

2

ProductRecalls,IncludingRemovals

andCorrections

GuidanceforIndustry

TableofContents

TABLEOFCONTENTS2

I.INTRODUCTION:3

II.RECALLINFORMATIONSUBMISSIONTOTHEFDA5

III.RECALLNOTICETODIRECTACCOUNTCONSIGNEES13

IV.EVALUATIONOFTHERECALL15

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ProductRecalls,IncludingRemovals

andCorrections

GuidanceforIndustry

ThisguidancerepresentsthecurrentthinkingoftheFoodandDrugAdministration(FDAorAgency)onthistopic.ItdoesnotestablishanyrightsforanypersonandisnotbindingonFDAorthepublic.Youcanuseanalternativeapproachifitsatisfiestherequirementsoftheapplicablestatutesandregulations.Todiscussanalternativeapproach,contacttheFDAstaffresponsibleforthisguidanceaslistedonthetitlepage.

I.Introduction:

ThisguidancedocumentisintendedtoprovideguidanceandrecommendationstoFDA-

regulatedindustryregardingwhatinformationfirmsshouldgivetotheFoodandDrug

Administration(FDA)andhowtheyshouldnotifytheircustomersaboutproductrecalls.This

guidanceisintendedtoassistthosemembersofindustryregulatedbytheFDAinhandlingmostaspectsofaproductrecall,aswellassomeremovalsandcorrectionswhichdonotmeetthe

definitionofarecallunder21CFR7.3.TheguidanceincludesachecklistofdocumentationandinformationthatindustrycanprovidetotheFDAthatwillbeusedbyFDAtoevaluate,classify,monitorandauditproductrecalls.Variousstatutoryprovisionsandregulations,describedbelow,authorizetheFDAtorequirerecallsofcertainproductsinparticularcircumstances.Additionally,subpartCofpart7ofFDAregulations(21CFR7.40-59)providesgeneralguidanceforthe

voluntaryrecallofproducts,includingthoserecallsinitiatedbyafirmonitsownandatthe

FDA'srequest.Thisguidanceprovidesmorespecificrecommendationsandappliestovoluntaryand,totheextentthattheguidancedoesnotconflictwithstatuteorregulation,mandatoryrecallsofallFDA-regulatedproducts(i.e.,food,includinganimalfood;drugs,includinganimaldrugs;medicalandradiologicaldevicesandproducts;cosmetics;tobaccoproducts;andbiological

products.)

Certainstatutoryprovisionsauthorizemandatoryrecallsofinfantformula(FD&CAct§412(e)-(g)[21U.S.C.§350a(e)-(g)]),medicaldevices(FD&CAct§518(e)[21U.S.C.§360h(e)]),

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food(FD&CAct§423[21U.S.C.§350l]),tobaccoproducts(FD&CAct§908(c)[21U.S.C.§387h(c)]),electronicproducts(FD&CAct§535[21U.S.C.§360ll]),controlledsubstances

(FD&CAct§569D[21U.S.C.§360bbb-8d]),andbiologicalproducts(PublicHealthService

Act§351(d)[42U.S.C.§262(d)]).Additionally,FDAregulationssetforthspecific

requirementsformandatoryinfantformularecalls(subpartEof21CFRpart107),medical

devicecorrectionsandremovals(21CFRpart806),mandatorydevicerecalls(21CFRpart810),electronicproductnotificationsandcorrections(21CFRparts1003and1004)andmandatory

recallsforhumancells,tissues,andcellularandtissue-basedproducts(subpartFof21CFRpart1271).Inadditiontotherequirementsinthesestatutoryprovisionsandregulations,the

guidance'sspecificrecommendationsmayalsobeusefulforthesetypesofrecalls.Inthecontextofamandatoryrecall,thoseconditionsintheguidancethataresetforthinastatuteand/or

regulationarerequirements,ratherthanrecommendations.

TheFDAbelievesthatexpeditingrecallactivitiesisvital.RecallingfirmsareurgedtonotifytheappropriateFDADivisionRecallCoordinator(DRC)orCentercontactassoonasadecisionis

madethatarecallisappropriateand,iffeasible,priortotheissuanceofanoticetothepublicorwrittencommunicationstocustomers.Tolocateyourrecallcoordinator,pleasecheckthe

followingwebsite:

/safety/industry-guidance-recalls/ora-recall-coordinators

.

Afterthedecisiontorecallismade,werecommendthatyouestablishcommunicationwitha

DRCorCentercontactandsubmittheinformationoutlinedinthisguidancetoyourFDAcontactassoonaspossible.Wealsorecommendthatyousubmitinformationasitbecomesavailabletoyouratherthanwaitinguntilallapplicableinformationisready.ThiswillallowtheFDAthe

opportunitytoreviewandcommentonyourrecallstrategyandtoofferguidanceandassistanceinyourrecallprocess.

FDAguidancedocuments,includingthisguidance,donotestablishlegallyenforceable

responsibilities.Instead,guidancesdescribetheFDA'scurrentthinkingonatopicandshouldbeviewedonlyasrecommendations,unlessspecificregulatoryorstatutoryrequirementsarecited.TheuseofthewordshouldinFDA'sguidancemeansthatsomethingissuggestedor

recommended,butnotrequired.

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II.RecallInformationSubmissiontotheFDA

WerecommendthatyouincludethefollowinginformationinyourrecallsubmissiontotheFDA,asapplicabletothetypeofproductbeingrecalled:

1

,

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1.PRODUCTINFORMATION.Werecommendyouprovidethefollowing:

oProductname(includebrandnameandgenericname)

oModel,catalogue,orproductordernumber(s)

oProductimage

oDescriptionoftheproduct

Includeiftheproductispowder,liquid,tablet,capsule,etc.

Includetheintendeduseorindications.

oForanimalproducts,includetheintendedspeciesandlifestage

Iftheproductisperishable,includetheexpectedshelflife.

Includethetypeofpackaging(i.e.,box,flexibleplastic,glass,bulk).

Twocompletesetsofalllabeling.Include:

Productlabeling(includingallprivatelabels)

Individualpackagelabel

Caselabel(photocopyacceptable)

Packageinserts

Directionsforuse

Promotionalmaterial(ifapplicable)

AdditionalrecommendedinformationforDrugrecalls:

1TherecommendationsinSectionIIdonotapplytoproductsregulatedbyFDA’sCenterforBiologicsEvaluationandResearch(CBER).CBERhasestablishedtheDirectRecallClassificationprogramastheprimarymeansbywhichfirmscommunicatewithCBERregardingarecall.FurtherinformationontheDirectRecallClassificationprogrammaybefoundat

/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm

172970.htm

.

2Someinformationisrequiredtobereportedforcertainproducts,suchasmedicaldevicecorrectionsandremovalsunder21CFR806.10.Firmsshouldbefamiliarwithmandatoryreportingrequirementsspecifictotheirproduct

eveniftheyarenotnotedinthisguidance.

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oNDA/ANDA/(C)NADA/ANADA/MIFNumber

oNDCNumber

oIndicateifthedrugisprescriptionorOTC

oIndicatethestrength

oDescribetherouteofadministration

oBlueBirdlabel(forTypeAmedicatedarticlesforanimals)AdditionalrecommendedinformationforMedicalDevicerecalls:

o510(k)/IDE/PMAnumber

oSpecifiyingwhetherthemedicaldeviceisforhumanand/oranimaluse

AdditionalrecommendedinformationforElectronicProductnotificationsandcorrections,ifapplicable:

oProvideresponsestotherequirementsof21CFR1003and1004

oPerformanceStandard

2.CODES(ProductionIdentificationNumbers).Werecommendyouprovidethefollowing:

oLot/UnitNumbers

NOTE:If"alllots"areinvolvedortheproductisnotcoded,explainhownon-recalled,orreintroducedproductmaybedistinguishedfromproductsubjecttorecall.

Provideanexplanationofthelotnumbercodingsystem,includingspecificcodesforimpactedproducts

oExpirationdate(s)oruse-bydate(s)orexpectedshelflifeofproduct.

oSerialnumbers(medicaldevices)

oUPCcodes

oUDI(ifapplicable)

oProductCode(medicaldevices/electronicproducts)

3.RECALLINGFIRM.Werecommendyouprovidethefollowing:

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o

oFirmname,address,city,state,zipcode

oThefirmtype(e.g.,manufacturer,importer,broker,repacker,own-labeldistributor)

ContactsforRecallingFirm:

oName,title,phonenumber,faxnumber,ande-mailaddressforrecallcontact(thepersoncorrespondingwithFDAabouttherecall)

oName,title,address,phonenumber,faxnumber,ande-mailaddressofthemostresponsibleindividual(e.g.,owner,plantmanager,agent-in-charge)

oName,title,phonenumber,faxnumber,ande-mailaddressforpubliccontact

4.MANUFACTURER.Werecommendyouprovidethefollowing:

oFirmname,address,city,state,zipcode

oFDAregistrationnumber,ifapplicable.

5.IDENTIFYTHEFIRMRESPONSIBLEFORTHEVIOLATION/PRODUCTPROBLEM.Werecommendyouprovidethefollowing:

oFirmname,address,city,state,zipcode

6.REASONFORTHERECALL.Werecommendyouprovidethefollowing:

oThedatethefirmmadethedecisiontoconductarecall

oExplainindetailhowtheproductisviolative.

oExplainhowtheviolationaffectstheperformanceandsafetyoftheproduct.(Alsosee#7,HealthHazardAssessment.)

oIftherecallisduetothepresenceofaforeignobject,describetheforeignobject'ssize,composition,hardness,andsharpness.

oIftherecallisduetothepresenceofachemicalcontaminant(e.g.,cleaningfluid,machineoil,paintvapors),explainthelevelofcontaminantintheproduct.If

applicable,providethelabeling,alistofingredientsandtheSafetyDataSheetforthecontaminant.

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oIftherecallisduetoafailureoftheproducttomeetproductspecifications,

providethespecificationsandreportalltestresults.Providecopiesofanysampleanalysis.

oIftherecallisduetothepresenceofapathogen,providethetestresultsifrequested.

oIftherecallisduetoalabelissue(e.g.,amissingorinaccurateingredientlist),provideandidentifythecorrectandincorrectlabel(s),description(s),and

formulation(s).

oExplainhowtheproblemoccurredandthedate(s)itoccurred.

oExplainhowtheproblemwasdiscoveredandthedateitwasdiscovered.

oExplainiftheproblemaffectsallunitssubjecttorecall,orjustaportionoftheunitsinthelotssubjecttorecall.

oExplainwhythisproblemaffectsonlythoseproducts/lotssubjecttorecall.

oProvidedetailedinformationoncomplaintsassociatedwiththeproduct/problem,suchasreportsofadverseevents:

Date(s)ofcomplaint(s)

Numberofcomplaints

Description(s)ofcomplaint(s)–includedetailsofanyinjuryorillnessand,ifmedicalattentionwassought,anyconfirmeddiagnoses

LotNumber(s)/SerialNumber(s)involved

MedicalDeviceComplaints–includecopiesofMedWatch-MDRs

oIfastateagencyisinvolvedinthisrecall,identifytheagencyandacontact.

oDrugrecalls(NDA/ANDA/(C)NADA/ANADA/IndexListedproducts)-providedetailsforanyFieldAlertsubmitted

7.HEALTHHAZARDASSESSMENT.Werecommendyouprovidethefollowing:

oYourassessmentofthehealthhazardassociatedwiththeviolation.

NOTE:Arecalldecisiondoesnotdependsolelyonthehealthriskoftheproduct.Violativeproductswherenohealthhazardexistsarestillin

violationofthelawandmaywarrantbeingvoluntarilyrecalled.

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8.VOLUMEOFRECALLEDPRODUCT.Werecommendyouprovidethefollowing:

oTotalquantityforrecall

oDate(s)produced

oQuantitydistributed

oDate(s)distributed

oQuantityheldbyrecallingfirmanditsdistributioncenters.

oHowtheproductisbeingquarantined

oIftheinformationisreadilyavailable,estimatetheamountofaffectedproductremaininginthemarketplaceforthefollowingdirectaccountsconsignees

(customersyouselldirectlyto):

wholesalelevel

distributorlevel

retaillevel

pharmacy,clinic,orveterinarylevel(drugs)

consumeroruserlevel,whereappropriate(e.g.,medicaldevices)

oThestatus/dispositionofmarketedproduct,ifknown,(e.g.,used,implanted,usedinfurthermanufacturing,ordestroyed).

9.DISTRIBUTIONPATTERN.Werecommendyouprovidethefollowing:

oNumberofdirectaccountsbytype,forexample:

wholesalers/distributors

repackers

manufacturers

retail

pharmacy/clinic/veterinarian

users(medicaldevices–hospitals,clinics,laboratories)

consumers(internetorcatalogsales)

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federalgovernment

foreign(specifywhethertheyarewholesaledistributors,retailersorusers)

oGeographicareasofdistribution,includingforeigncountries.

oAdirectaccountlist(name,address,city,state,contactname,phonenumber)totheDRC.Atminimum,thelistshouldincludethe"shipto"addresses.If

available,provideacopyofthislistinasortableelectronicspreadsheetformat(e.g.,aMicrosoftExcelfile.)Whenfeasible,youshouldincludeotherrelevantfieldsinthespreadsheetthatmighthelpfacilitatefollow-upbyFDA(e.g.,lot

numbers,shipmentdates)Youshouldincludeanyforeigncustomersandfederalgovernmentcustomers(e.g.,USDAagencies,DepartmentofVeteransAffairs,DepartmentofDefense).

Indicatewhatthelistrepresents(i.e.,allcustomerswhowereshipped

recalledproduct;allcustomerswhoweresoldrecalledproduct;all

customerswhomayhavebeenshippedorsoldrecalledproductbecauseitwassoldtothemwithintheapplicabletimeperiod).MostFDA-regulatedproductsaresubjecttoregulationsthatrequiredistribution

recordkeeping.

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Tothefullestextentavailableorrequired,asapplicable,youshouldprovideanexactdistributionlist(nota"mayhave"list)fortherecalledlot(s).

oWasproductsoldunderagovernmentcontract?Ifyes,providethecontractnumber,contractdateandimplementationdate.Ifno,indicateso.

oWasproductsoldtoanyfederal,state,orlocalagencyinvolvedinaschoollunchprogram?Ifyes,listthecustomersandprovidethequantitysold,thesaledate

andtheshipmentdate.

Inaddition,werecommendthatyounotifyboth"shipto"and"billto"customersoftherecallsothat:

o"Shipto"customerscanretrievetheproductfromtheirlocation.

3Forvariousrequirementsrelatedtodistributionrecordkeepingsee,e.g.,21CFR211.196(humanandanimal

drugs);21CFR820.160(medicaldevices);21CFR117.139(humanfood)21CFR111.475(dietarysupplements);21CFR106.100(g)(infantformula);21CFR113.100(f)(lowacidfoods);21CFR114.100(d)(acidifiedfoods);21CFR507.38(animalfood);21CFR226.110(TypeAmedicatedarticles);21CFR225.202(medicatedanimalfeed);21CFR1270.35(c)(humantissue);21CFR1271.265(e)(humancells,tissues,andcellularandtissue-based

products);and21CFR1.980(k)and800.55(k)(postadministrativedetentionrecordkeeping).

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o"Billto"customers,ifresponsible,caninitiatethesub-recall.

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10.RECALLSTRATEGY.Werecommendyouprovidethefollowing:

oIndicatethelevelinthedistributionchaintowhichyouareextendingtherecall.(e.g.,wholesale,retail,pharmacy,orconsumer/user,suchaspatientorphysician)

Ifyourrecallonlyextendstothewholesale/distributorlevel,thenwerecommendthatyouexplainyourrationalefornotrecallingto

retail/pharmacy/userlevel.

oIndicatethescopeoftherecall(i.e.,whichlotsareaffected).Indicateyour

strategyforexpandingthescopeoftherecallshouldadditionallotsbeshowntobeaffected.

oIndicatethemethodofrecallcommunication(e.g.,mail,phone,facsimile,e-mail).Werecommendthatyouincludeawrittencommunicationsocustomerswillhavearecordoftherecallandyourinstructions.

oWhenyourcustomersoftherecalledlot(s)canbequicklydeterminedwith

accuracyandcompleteness(e.g.,viadistributionrecords),werecommend

directingrecallcommunicationstoonlythosecustomerswhoreceivedthe

recalledlots.Althoughindiscriminatelysendingthenotificationtoallcustomersmaybesimpler,thispracticedesensitizescustomerstorecallnotices,manyof

whomreceivehundredsofinapplicablerecallnoticesperyear.Ifused,indicatehowwrittencommunicationswillbesenttocustomers(e.g.,e-mail,overnightmail,firstclassmail,certifiedmail,facsimile).

oIfinitialcommunicationismadebyphone,provideacopyofthephonescript.

oIfyouhaveawebsite,considerpostingtherecallcommunicationonthewebsiteasanadditionalmethodofcustomernotificationabouttherecall.(Note:Thisisnotrecommendedasasolemeansofcustomernotification.)

oProvidewhatyouhaveinstructedcustomerstodowiththerecalledproduct.

oIdentifyarecallcontactforeachcustomerandaddressrecallcommunicationstothoserecallcontactstoreducethepotentialforthecommunicationlettertogetmisdirected.

4Sub-recallsoccurwhenaconsigneefurtherdistributesarecalledproductwithoutchangingtheproduct.Asub-recallisanactiontakenbythatconsigneetonotifyitsownaccounts.

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oIftheproductshouldbereturned,refunded,orreplaced,explainthemechanicsofsuchprocess.

oIfthisrecallwillcreateamarketshortagethatmayimpactconsumers,explainthesituationandprovideanydraftplantoaddresstheshortage.

oDescribeyourrecalleffectivenesscheckstrategy.Includeyourstrategyforhowtotrackandidentifyyourcustomerswhofailtorespondtoyourrecall

communications,andwhatadditionalstepsyouwilltaketonotifynon-responsivecustomers.

oDetermineandprovideyourcourseofactionforout-of-businesscustomersoftherecalledproduct.

oProvideaproposedmethodfordestroyingtherecalledproduct,ifapplicable.

oIftheproductcanbereconditioned(broughtintocompliancewiththelaw),

explainhowandwherethereconditioningwilltakeplace.PleaseprovidedetailsofthereconditioningplantoyourFDAcontactbeforeimplementation.All

reconditioningmustbeconductedunderanyapplicablecurrentgoodmanufacturingpractices.

Describehowtherecalled(i.e.,pre-reconditioned)productwillbe

segregatedandidentifiedsoitisnotconfusedwithreconditionedproduct.Reconditionedproductneedstobesimilarlydistinguishedfromproduct

subjecttorecallthathasnotbeenreconditioned.

Inaddition,werecommendthat:

oYoucontactyourFDADRCpriortoproductdestruction.TheFDAwillreviewyourproposedmethodofdestructionandmaychoosetowitnessthedestruction.

oYouandyourcustomerskeepadequatedocumentationofproductdestruction(regardlessofwhetherdestructionwaswitnessedbyanFDAinvestigator).

oFieldcorrections(e.g.,productrelabeling)beperformedbyrecallingfirm

representatives,orundertheirsupervisionandcontrol.Wedonotrecommendthatadisinterestedpartysuchasawholesalerorretailerberesponsibleforfield

corrections.Fordrugrecalls:misbrandeddrugsforre-labelingshouldbereturnedtotherecallingfirm.

oYoucontactyourDRCpriortoreleasingreconditionedgoods.

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III.RecallNoticetoDirectAccountConsignees

1.Forguidanceonissuingpublicwarnings,pleasereferenceFDA'sguidanceon

Public

WarningandNotificationofRecallsUnder21CFRPart7,SubpartC

(issuedin

February,2019

/downloads/Safety/Recalls/IndustryGuidance/UCM592851.pdf

)

2.GUIDANCEFORWRITTENRECALLCOMMUNICATIONSTODIRECT

ACCOUNTCONSIGNEES:Recallcommunicationsshouldbeflaggedinlargeboldprint"URGENT:[insert"FOOD,""DRUG,""MEDICALDEVICE,"etc.]

RECALL[orCORRECTION]."Ifused,envelopesshouldbesimilarlyflagged.Theterms"marketwithdrawal"or"stockrecovery"shouldnotbeusedbecausetheyhaveseparateregulatorydefinitionsanddonotaccuratelyconveythedefinitionofarecall.

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TheFDArecommendsthatyouincludethefollowinginformationinawrittenrecall

communicationtoyourdirectaccountconsignees:

a.PRODUCTIDENTIFICATION:

Includeanaccurateandcompletedescriptionoftheproductandanycodesusedtoidentifytheproduct,e.g.,lot/unitnumbers,expirationdate,serialnumbers,catalognumbers,modelnumbers,UDI,andUPCcodes.

Considerincludingacopyoftheproductlabelwiththerecall

communication.Thiscouldbehelpfulinidentifyingandremovingtherecalledproduct.

b.DESCRIPTIONOFTHEPROBLEM:

Identifythereasonfortherecallandanypotentialhealthhazard(s)

associatedwithit.Ensurethestatementisclear,directlyconveystherisk,andpromptsanurgentresponsebythereader.

c.DEPTHOFTHERECALL:

Therecallcommunicationshouldclearlyidentifythedepthtowhichtherecallistoextend(e.g.,wholesale,retail,consumeroruserlevel).For

example,iftherecallistotheretaillevel,astatementshouldread"Thisrecallshouldbecarriedouttotheretaillevel."

Iftheproductcouldhavebeenfurtherdistributedbyyourdirectaccountconsigneestotheircustomers,thenyoushouldincludeinstructionstosub-recall.Sub-recallinstructionsshouldalsoincludeastatementaboutthe

depthoftherecall,e.g.,"Ifyouhavefurtherdistributedthisproduct,

5See21CFR7.3(g),(h),(j),and(k)forthedefinitionsof“recall,”“correction,”“marketwithdrawal,”and“stockrecovery,”respectively.

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pleaseidentifyyourcustomersandnotifythematonceofthisproductrecall.Thisrecallshouldbecarriedouttotheretaillevel."

Ifyourdirectaccountconsigneesareinstructedtoconductsub-

recalls,werecommendthatyouprovidethemwiththedaterangethattherecalledproductwasdistributed.Wholesalers/distributorsmayneedthisinformationtoidentifycustomerstheyshipped/soldrecalledproductto.

Ifapplicable,considerprovidingasub-recallletterwithyour

communicationpackageforyourdirectaccountconsigneestofurthernotifytheirsubaccounts.Thisbetterensuresthatthe

informationprovidedtosubaccountsisaccurateandcomplete.

d.INSTRUCTIONS:

Yourrecallinstructionstoyourdirectaccountconsigneesshouldbeclear.Forexample:

Removeproductfromsale

Ceasedistribution

Sub-recall(ifappropriate)

Returnorcorrectproduct

Includeareturnresponsecard/form.Yourdirectaccountconsignees

shouldbeaskedtoindicatewhethertheyfollowedeveryinstructiononthereturnresponsecard/form.Includeaspacefortheconsignee’ssignatureanddate.

Werecommendthatyouprovideexamplesofallrecallcommunications(includingletters,attachments,envelope)toyourDRC.

3.IMPORTANT:Allcustomersinthedistributionchainshouldbenotifiedoftherecall,preferablyinwriting.Herearesomeexamplesofwhythisisimportant.

a.Inthecaseofahumandrugrecall,theFDAdoesnotbelieveitisappropriateforasalesrepresentativetovisitadoctor'sofficeandremoveproductwithout

notifyingthephysicianorresponsiblestaffoftherecall.Physiciansmaybe

treatingpatientsthatmaysufferorhavesufferedsomeadverseeffectfromthe

drugsubjecttorecall.Withknowledgeoftherecallandthereasonfortherecall,

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thephysiciancanbetterevaluateapatient'sconditionandprovideappropriatepatientcare.

b.Inthecaseofproductssoldatretailstores,theFDAdoesnotbelieveitis

appropriateforaproductsalespersonorbrokerrepresentativetoremoveproductfromretailshelveswithoutinformingstoremanagementoftherecall.Failuretoinformstoremanagementoftherecallcouldresultinproductthatisinstorage,intransittothestore,orreturnedbycustomers,beingofferedforsaleatalatertime.Thesalespersonorbrokerrepre