Guidance for Industry: Product Recalls, Including Removals and Corrections

Transcription

1 Guidance fr Industry: Prduct Recalls, Including Remvals and Crrectins This guidance dcument is intended t prvide guidance and instructins t FDA regulated industry fr btaining infrmatin t help fulfill the Agency s plans regarding prduct recalls. It represents the agency s current thinking n prduct recalls. This guidance des nt create r cnfer any rights fr r n any persn and des nt perate t bind the Fd and Drug Administratin (FDA) r the public. An alternative apprach may be used if such apprach satisfies the requirements f the applicable statute, regulatins, r bth. T discuss an alternative apprach, cntact the FDA staff respnsible fr implementing this guidance. If yu cannt identify the apprpriate FDA staff, call the apprpriate number listed n the title page f this guidance. This guidance is available electrnically t the public. Date Issued: 11/3/03 INTRODUCTION: U.S. Department f Health and Human Services Fd and Drug Administratin Office f Regulatry Affairs Office f Enfrcement Divisin f Cmpliance Management and Operatins 1350 Piccard Drive HFC-210 Rckville, MD (301) This guidance is intended t assist thse members f industry regulated by the Fd and Drug Administratin (FDA) in handling all aspects f a prduct recall, including all crrectins and remvals. The guidance includes a checklist f dcumentatin and infrmatin that FDA utilizes t evaluate, classify, mnitr and audit prduct recalls. Varius statutry prvisins and regulatins, described belw, authrize FDA t require recalls f certain prducts in particular circumstances. Additinally, Subpart C f Part 7 f FDA regulatins (21 CFR ) prvides general guidance fr the vluntary recall f prducts, including thse recalls initiated by a firm n its wn and at FDA's request. This guidance prvides mre specific recmmendatins and applies t bth mandatry and vluntary recalls f all FDAregulated prducts (i.e. fd, including animal feed; drugs, including animal drugs; medical and radilgical devices; csmetics; human bilgical prducts including bld; and human tissue.) This is a level 2 guidance dcument published fr immediate implementatin in accrdance with FDA's gd guidance practices (21 CFR ). This guidance sets frth the agency's existing practices in the handling f recalls. Interested parties may submit cmments n this guidance t the Divisin f Dckets Management (HFA-305), Fd and Drug Administratin, 5630 Fishers Lane, rm. 1061, Rckville, MD All cmments shuld be identified with the dcket number listed in the ntice f availability that publishes in the Federal Register. Page 1 f 9

2 Guidances describe the Agency's current thinking n a tpic and shuld be viewed nly as recmmendatins, unless specific regulatry r statutry requirements are cited. The use f the wrd shuld in Agency guidances means that smething is suggested r recmmended, but nt required. Certain statutry prvisins authrize mandatry recalls f infant frmula (21 USC 350a(e)-(g)), medical devices (21 USC 360h(e)), and human bilgical prducts (42 USC 262). Additinally, FDA regulatins set frth specific requirements fr mandatry infant frmula recalls (Subpart E f 21 CFR Part 107), medical device crrectins and remvals (21 CFR Part 806), and mandatry human tissue recalls (Subpart D f 21 CFR Part 1270). In additin t the requirements in these statutry prvisins and regulatins, the guidance's specific recmmendatins wuld als apply t these types f recalls. In the cntext f a mandatry recall, thse cnditins in the guidance that are already set frth in a statute and/r regulatin wuld be requirements, rather than recmmendatins, under the applicable statute and/r regulatin. FDA believes the cperatin f manufacturers and distributrs in expediting recall activities is vital because f the determinatin that a distributed prduct is ptentially hazardus t the public r animals and/r is in vilatin f the Federal Fd, Drug, and Csmetic Act (the Act). Recalling firms are urged t ntify the lcal FDA District Recall Crdinatr as sn as a decisin is made that a recall is apprpriate and prir t the issuance f press r written ntificatin t custmers. Fr yur lcal recall crdinatr, please check the fllwing website: 1 It is recmmended that yu submit the infrmatin utlined in this guidance t yur lcal FDA District Recall Crdinatr as sn as pssible after the decisin t recall is made and the crdinatr ntified. It is recmmended that yu d nt wait t submit this infrmatin until ALL applicable infrmatin is prepared and assembled prir t FDA ntificatin. This "early" ntificatin will allw FDA the pprtunity t review and cmment n yur written ntificatin and t ffer guidance and assistance in yur recall prcess. A. Recall Submissin t FDA We recmmend that yu include the fllwing infrmatin in yur recall submissin: 1. PRODUCT INFORMATION: Prduct name (include brand name and generic name) Mdel, catalgue, r prduct rder number(s) Descriptin f the prduct Include if prduct is pwder, liquid, tablet, capsule, etc. Include the intended use r indicatins. If the prduct is perishable, include the expected shelf life. Include type f packaging (i.e. bx, flexible plastic, glass). TWO COMPLETE SETS OF ALL labeling t yur Lcal FDA District Recall Crdinatr. Include: Prduct labeling (including ALL private labels) Individual package label Case label (phtcpy acceptable) Package Inserts Directins fr Use Prmtinal Material (if applicable) Page 2 f 9

3 Additinal infrmatin fr Drug recalls: NDA/ANDA/NADA Number NDC Number Indicate if prescriptin r OTC Strength Rute f Administratin Additinal infrmatin fr Medical Device recalls: 510(k)/IDE/PMA number Additinal infrmatin fr Bilgical recalls: License number Registratin number 2. CODES (Prductin Identificatin Numbers): Lt/Unit Numbers (NOTE: If "all lts" are invlved r the prduct is nt cded, explain hw nn-recalled, r reintrduced prduct may be distinguished frm prduct subject t recall. Prvide an explanatin f yur lt number cding system.) Expiratin date(s) r Use by date(s) r Expected shelf life f prduct. Serial numbers (medical devices) UPC cdes 3. RECALLING FIRM: Firm name, address, city, state, zip cde Identify firm type (i.e. manufacturer, imprter, brker, repacker, wn-label distributr) CONTACTS fr Recalling Firm: Name/title/phne/fax number/ address fr RECALL cntact Name/title/address/phne/fax number f the mst respnsible individual fr the recalling firm Name/title/phne/fax number/ address fr public cntact 4. MANUFACTURER: Firm name, address, city, state, zip cde FDA registratin number, if applicable 5. IDENTIFY FIRM RESPONSIBLE FOR THE VIOLATION/PROBLEM: Firm name, address, city, state, zip cde 6. REASON FOR THE RECALL: Explain in detail hw prduct is defective and/r vilative. Explain hw the defect affects the perfrmance and safety f the prduct. (Als see #5, Health Hazard Assessment) If the recall is due t the presence f a freign bject, describe the freign bjects' size, cmpsitin, hardness, and sharpness. If the recall is due t the presence f a cntaminant (cleaning fluid, machine il, paint vaprs), explain level f cntaminant in the prduct. Prvide labeling, a list f ingredients and the Material Safety Data Sheet fr the cntaminant. If the recall is due t failure f the prduct t meet prduct specificatins, prvide the specificatins and reprt all test results. Prvide cpies f any sample analysis. Page 3 f 9

4 If the recall is due t a label/ingredient issue, prvide and identify the crrect and incrrect label(s), descriptin(s), and frmulatin(s). Please explain hw the prblem ccurred and the date(s) it ccurred. Explain hw the prblem was discvered and the date discvered. Please explain if the prblem/defect affects ALL units subject t recall, r just a prtin f the units in the lts subject t recall. Explain why this prblem affects nly thse prducts/lts subject t recall. Prvide detailed infrmatin n cmplaints assciated with the prduct/prblem: Date f cmplaint Descriptin f cmplaint -include details f any injury r illness Lt Number/Serial Number invlved Medical Device Cmplaints - include cpies f MedWatch-MDRs If a State agency is invlved in this recall, identify Agency and cntact. Drug recalls (NDA/ANDA/NADA/ANADA prducts) prvide details fr any Field Alert submitted 7. HEALTH HAZARD ASSESSMENT: Please prvide yur assessment f the health risk assciated with the deficiency. NOTE: A recall decisin des nt depend slely n the health risk f the prduct. Defective prducts and misbranded prducts where n health hazard exists are still in vilatin f the law and shuld be recalled. Fr recalls f prducts such as human tissue and bilgical prducts, including bld prducts, due t dnr suitability/viral marker testing, prvide cpies f: dnr screening frm test results, including viral marker test results fr implicated unit, viral marker test results fr subsequent dnatins, and, if available, cnfirmatry test results. SOPs that shw the acceptance criteria fr dnr screening and/r viral marker testing, that was nt met fr the prduct(s) subject t recall. 8. VOLUME OF RECALLED PRODUCT: Ttal quantity prduced Date(s) prduced Quantity distributed Date(s) distributed Quantity n HOLD by Recalling firm and its distributin centers. Indicate hw the prduct is being quarantined Estimate amunt remaining in marketplace distributr level retail level pharmacy r veterinary level (drugs) user level (i.e. Medical Devices) Prvide the status/dispsitin f marketed prduct, if knwn, (e.g. used, transfused, implanted, used in further manufacturing, r destryed). 9. DISTRIBUTION PATTERN: Number f DIRECT accunts (custmers yu sell directly t) by type, fr example: whlesalers/distributrs repackers manufacturers retail/pharmacy/veterinarian users (medical devices - hspitals, clinics, labratries) cnsumers (internet r catalg sales) federal gvernment cnsignees Page 4 f 9

5 freign cnsignees (specify whether they are whlesale distributrs, retailers r users) Gegraphic areas f distributin, including freign cuntries. Prvide a cnsignee list (names/address/city/state/cntact name/phne number) t the lcal District Recall Crdinatr. Be sure t include any freign (including Canadian) custmers and federal gvernment cnsignees (USDA agencies, Veterans Affairs, Department f Defense) Indicate what the cnsignee list represents (i.e. all custmers wh were shipped recalled prduct; all custmers wh were sld recalled prduct; all custmers wh may have been shipped r sld recalled prduct because it was sld t them within the applicable time perid.) Was prduct sld under a gvernment cntract? If yes, prvide cntract number, cntract date and implementatin date. If n, indicate s. Was prduct sld t any federal, state, r lcal agency invlved in the schl lunch prgram? If yes, list the cnsignees and prvide quantity and sale and shipment date. In additin, it is recmmended that yu ntify bth "ship t" and "bill t" custmers f the recall s that "Ship t" custmers retrieve the prduct frm their lcatin. "Bill t" custmers, if respnsible, initiate the subrecall. 10. RECALL STRATEGY: Indicate the level in the distributin chain t which yu are extending the recall. (i.e. whlesale/retail/pharmacy/medical user) If yur recall nly extends t the whlesale/distributr level, we recmmend that yu explain yur ratinale fr nt recalling t retail/pharmacy level. Indicate the methd f ntificatin (i.e. mail, phne, facsimile, ). It is advisable t include a written ntificatin s custmers will have a recrd f the recall and yur instructins. Indicate hw letters will be sent t custmers (e.g. vernight mail, first class mail, certified mail, facsimile) If initial ntificatin is by phne, prvide a cpy f the phne script t FDA. If yu have a web site, yu shuld cnsider psting the recall ntificatin n the web site as an additinal methd f recall ntificatin. (Nte: This is nt recmmended as a sle means f custmer ntificatin.) Reprt n what yu have instructed custmers t d with the recalled prduct. It is helpful fr recalling firms t knw the name and title f the Recall Cntact fr each f its cnsignees. Addressing a recall ntificatin letter t a recall cntact will expedite the recall prcess and reduce the ptential fr the ntificatin letter t get misdirected. If prduct is t be returned, explain the mechanics f the prcess. Explain if this recall will create a market shrtage that will impact n the cnsumer. Reprt n recall effectiveness check strategy. Include yur actins fr nn- respnders. See: < 2 > Determine and prvide yur curse f actin fr ut-f-business distributrs. Prvide a prpsed methd f destructin, if applicable. If the prduct is t be "recnditined", explain hw and where the recnditining will take place. Please prvide details f the recnditining plan t yur lcal FDA District Recall Crdinatr befre implementatin. All recnditining must be cnducted under any applicable CGMPs. Describe hw recnditined prduct will be identified s it is nt cnfused with recalled (pre-recnditined) prduct. Page 5 f 9

6 In additin, we recmmend that: Yu cntact yur lcal FDA District Recall Crdinatr prir t prduct destructin. FDA will review yur prpsed methd f destructin and may chse t witness the destructin. The recalling firm and custmers keep adequate dcumentatin f prduct destructin (and whether r nt destructin was witnessed by an FDA investigatr). Field crrectins, (i.e. prduct relabeling), be perfrmed by recalling firm representatives, r under their supervisin and cntrl. It is nt recmmended that a disinterested party such as a whlesaler r retailer be respnsible fr field crrectins. Fr Drug Recalls: Misbranded drugs fr re-labeling shuld be returned t the recalling firm. Yu cntact yur lcal District Recall Crdinatr prir t release f recnditined gds. B. Public Ntificatin 1. PRESS RELEASE: In a situatin where the prduct may pse a significant health hazard and recalled prduct is in the hands f cnsumers, a press release is usually apprpriate. Issuance f a press release shuld be the highest pririty and it shuld be issued prmptly. Unique situatins will be handled n a case-by-case basis. Yu shuld cnsult with yur lcal District Recall Crdinatr befre issuance f a press release whenever pssible. A jint press release may benefit the firm and FDA by alerting the public t a serius health hazard r situatins deemed t be in the public interest. Mdel Press Release Guidance is available n the FDA website at: 3 T assure the bradest cverage, press releases shuld be issued thrugh the Assciated Press (AP). Fr lcal and/r reginal recalled prduct distributin, yu shuld cntact the Assciated Press ffices in the States in which the prduct was distributed. Assciated Press cntacts can als be fund n their website at: 4. Click n Cntact AP at tp f the hme page. Fr recall press releases needing natinal media cverage (8 states r mre), firms shuld call the Assciated Press, Washingtn, DC Bureau at during business hurs. After 5:00 p.m. Eastern time, cntact the AP news desk at The facsimile number is Yur lcal District Recall Crdinatr can ffer guidance. NOTE: Fr thse recalls where FDA believes a Press Release is warranted, the Agency will issue a Press Release if the firm has failed t d s, r if the firminitiated press release is nt adequate. 1. GUIDANCE FOR WRITTEN RECALL NOTIFICATION LETTERS: Recall Ntificatins shuld be flagged in large bld print "URGENT: [insert "FOOD", "DRUG", "MEDICAL DEVICE", etc.] RECALL r CORRECTION. Envelpes shuld be similarly flagged. FDA recmmends that yu include the fllwing infrmatin in a recall ntificatin: a. PRODUCT IDENTIFICATION: Page 6 f 9

7 Include an accurate and cmplete descriptin f the prduct and any cdes used t identify the prduct, e.g. lt/unit numbers, expiratin date, serial numbers, catalg numbers, mdel numbers, and UPC cdes. Cnsider including a cpy f the prduct label with the recall ntificatin. This culd be helpful fr whlesalers and retailers in identifying and remving the recalled prduct. b. DESCRIPTION OF THE PROBLEM: Identify the prblem and any ptential health hazard(s) assciated with it. c. DEPTH OF THE RECALL: The recall ntificatin shuld clearly identify the depth t which the recall is t extend (e.g. whlesale, retail, r user level). If the recall is t the retail level, a statement shuld read This recall is t the retail level. If the prduct culd have been further distributed by yur custmers, then yu shuld include instructins t subrecall. Subrecall instructin shuld als include the depth f the recall, e.g. If yu have further distributed this prduct, yu shuld ntify yur custmers t the retail level. If yur custmers are instructed t cnduct subrecalls, it is advisable t prvide them with the date range that the recalled prduct was distributed. Whlesalers/ distributrs may need this infrmatin in rder t identify custmers they shipped/sld recalled prduct t. Yu shuld cnsider prviding a subrecall letter with yur ntificatin package fr yur custmers t further ntify their sub accunts. Yu are then assuring that the infrmatin t sub accunts is accurate and cmplete. d. INSTRUCTIONS TO CUSTOMERS: Yur recall INSTRUCTIONS shuld be clear. Fr example: Remve prduct frm sale Cease distributin Subrecall (if apprpriate) Return prduct Explain prcedure fr prduct crrectin Include a RETURN RESPONSE card/frm. This return respnse card/frm shuld include all instructins frm yur recall letter. Yur custmers shuld be required t indicate that they fllwed every instructin. Prvide examples f ALL recall cmmunicatins (include letters, attachments, envelpe) t yur Lcal District Recall Crdinatr. IMPORTANT: All custmers in the distributin chain shuld be NOTIFIED f the recall, preferably in writing. Here are sme examples f why this is imprtant. 5. In the case f a human drug recall, FDA des nt believe it is apprpriate fr a salesman t visit a dctr's ffice and remve prduct withut ntifying the physician r respnsible staff. Physicians may be treating patients that may suffer r have suffered Page 7 f 9

8 sme adverse effect frm the drug subject t recall. With knwledge f the recall and the reasn fr the recall, the physician can better evaluate a patient's cnditin and prvide apprpriate patient care. 6. In the case f prducts sld at retail stres, FDA des nt believe it is apprpriate fr a salesman r brker representatives t remve prduct frm retail shelves withut infrming stre management f the recall. Failure t infrm stre management f the recall culd result in prduct that is in strage, in transit t the stre, r returned by custmers, being ffered fr sale. The salesmen r brker representatives may nt have knwledge r access t the recalled prducts stred in back rms. Recalled prducts that are in-transit t the stre wuld then be sld t custmers. Recalled prducts returned by custmers may be placed back n stre shelves. C. Evaluatin f the Recall 1. EFFECTIVENESS OF THE RECALL: It is the recalling firm s respnsibility t assure that the recall is effective. Therefre, we recmmend that yu cnsider effectiveness checks fr every recall. The purpse f an effectiveness check is t verify yur recall ntificatin letter was received by the custmer, that the custmer read and understd the letter and fllwed the recall instructins. The effectiveness check shuld als verify yur recall reached the apprpriate level in the distributin chain. The effectiveness check is yur means f evaluating the effectiveness f yur recall. If yur effectiveness checks indicate that the recall ntificatin was nt received, read and/r instructins fllwed, then yu shuld take necessary steps t make the recall effective. These steps may invlve sending ut a fllw up ntificatin that better identifies the prduct, better explains the prblem and/r prvides better instructins t custmers. Yur District Recall Crdinatr will prvide a cpy f a FDA dcument, Methds fr Cnducting Recall Effectiveness Checks. Nte: In additin t the effectiveness checks cnducted by recalling firms, FDA may als cntact a percentage f yur custmers (referred t as audit checks) as a means f assuring the recalling firm and its cnsignees are carrying ut their recall respnsibilities. If FDA's audit checks determine the recall t be ineffective, the recalling firm (r sub recalling firm if such is the case) will then be asked by FDA t take apprpriate actins, including re-issuing recall ntificatins. 2. RECALL STATUS REPORTS: Yu will be asked t prvide Recall Status Reprts after initiating a recall (usually n a mnthly basis but mre frequently when indicated) t yur lcal District Recall Crdinatr. The reprts requested will usually include the fllwing infrmatin: - Dates custmers ntified - Number f custmers ntified - Number f custmers respnding - Quantity f RECALLED prduct returned r accunted fr - Details f yur recall effectiveness checks 3. ROOT CAUSE OF THE PROBLEM THAT RESULTED IN THE RECALL: Page 8 f 9

9 We recmmend that yu prvide this infrmatin t yur lcal District Recall Crdinatr nce the rt cause has been established. It is imprtant t establish the rt cause f the prblem s that apprpriate preventative measures can be taken. 4. CORRECTIVE ACTIONS TO PREVENT FUTURE OCCURRENCES OF THE PROBLEM: We recmmend that yu explain the crrective actins planned r underway that will prevent a similar prblem frm ccurring. We further recmmend that yu prvide this infrmatin t yur lcal District Recall Crdinatr when it has been established. 5. TERMINATION OF THE RECALL: We recmmend that yu evaluate yur recall fr terminatin when all pssible custmer respnses have been received and it is reasnable t assume that the recalled prduct has been recvered, crrected, recnditined, r destryed. A final status reprt and dcumentatin f recalled prduct dispsitin shuld be prvided t yur lcal District Recall Crdinatr befre FDA will cnsider frmal terminatin f the recall actin. See: 5 Nte: Upn receipt f necessary terminatin infrmatin, the district s recall crdinatr will prepare a recall terminatin dcument fr Center and/r district management cncurrence. When cncurrence is btained, the district ffice will ntify the recalling firm that FDA cnsiders the recall terminated. Additinal Guidance and/r Requirements: 21CFR Part 7, Subparts A and C - Recalls - General guidelines 21CFR Part 107, Subpart E - Mandatry recall f Infant Frmula 21 CFR Part Human Tissue PHS Act - 42 U.S.C Mandatry recall f bilgical prducts 21 CFR Part Medical Device Crrectins and Remvals FD&C Act, 518(e) - Mandatry Device Recalls FDA DISTRICT RECALL COORDINATORS A current list f FDA recall crdinatrs can be fund n FDA s website at: 6 Page Last Updated: 08/05/2009 Page 9 f 9