Department  of Health  and Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
FDAS URGENT  NOTICE

JUNE  GIBBS BROWN 
Inspector  General 
JULY  1996 
OEI-07-94-00631  OFFICE  OF INSPECTOR  GENERAL 
The  mission of the  Office of Inspector  General  (OIG),  as mandated  by Public  Law 95-452, as 
amended,  is to protect  the integrity  of the Department  of Health  and Human  Services (HHS) 
programs  as well as the  health  and welfare  of beneficiaries  served  by those  programs.  This 
statutory  mission  is carried  out  through  a nationwide  network  of audits,  investigations,  and 
inspections  conducted  by three  OIG  operating  components:  the  Office of Audit  Services,  the 
Office of Investigations,  and the  Office of Evaluation  and Inspections.  The  OIG  also informs 
the Secretary  of HHS  of program  and management  problems  and recommends  courses  to 
correct  them. 
OFFICE  OF AUDIT  SERVICES 
The  OIGS  Office of Audit  Services  (OAS)  provides  all auditing  services  for HHS,  either  by 
conducting  audits with its own audit  resources  or by overseeing  audit work  done  by others. 
Audits  examine  the  performance  of HHS  programs  and/or  its grantees  and contractors  in 
carrying out  their  respective  responsibilities  and are intended  to provide  independent 
assessments  of HHS  programs  and operations  in order  to reduce  waste,  abuse,  and 
mismanagement  and to promote  economy  and efficiency throughout  the  Department. 
OFFICE  OF INVESTIGATIONS 
The  010s  Office of Investigations  (01)  conducts  criminal,  civil, and administrative 
investigations  of allegations  of wrongdoing  in HHS  programs  or to HHS  beneficiaries  and of 
unjust  enrichment  by providers.  The  investigative  efforts  of 01  lead to criminal  convictions, 
administrative  sanctions,  or civil money penalties.  The  01  also oversees  State  Medicaid  fraud 
control  units which investigate  and prosecute  fraud  and patient  abuse  in the  Medicaid  program. 
OFFICE  OF EVALUATION  AND INSPECTIONS 
The  OIGS  Office of Evaluation  and Inspections  (OEI)  conducts  short-term  management  and 
program  evaluations  (called  inspections)  that  focus on issues of concern  to the Department, 
the  Congress,  and the public.  The  findings  and recommendations  contained  in these  inspection 
reports  generate  rapid,  accurate,  and up-to-date  information  on the  efficiency, vulnerability, 
and effectiveness  of departmental  programs. 
This report  was prepared  in the  Kansas  City Regional  Office under  the  direction  of James  H. 
Wolf, Regional  Inspector  General.  Project  staffi 
Region  Headquarters 
Raymond  Balandron,  Project  Leader	 Mary Beth  Clarke,  Program  Specialist 
Mark  Krushat,  Branch  Chief 
To obtain  a copy of this report,  call the Kansas  City Regional  Office  at (800) 241-2527.  Department  of Health  and Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
FDAS  URGENT  NOTICE

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0EI-07-94-o0631  NOTICE 
FDAS  URGENT 
PURPOSE 
The  purpose  of this  inspection  was  to  assess  the  effectiveness  of the  Food  and  Drug 
Administrations  (FDA)  Urgent  Notice  on  recalled  blood  glucose  test  strips,  released 
toretail  pharmacies  Octoberll,  1995. 
RECAU  AND  URGENT  NOTICE  OF  DEFECTIVE  TEST  STRIPS 
The  FDAs  Center  for  Devices  and  Radiological  Health  (CDRH)  is responsible  for 
regulating  devices  and  radiological  health  which  includes  identi&ing  and  addressing 
postmarked  safety  questions  that  arise.  In dealing  with these  issues,  FDA  will 
occasionally  notify members  of the  heahh  care  community  to inform  them  of the 
problem  and  to provide  important  follow up instructions  to prevent  further  recurrence. 
In January  1995, a manufacturer  of blood  glucose  test  strips voluntarily  recalled 
certain  lots of test  strips  and  in June  1995 extended  the  voluntary  recall  to include  all 
lots  current  in the  marketplace.  Patients  with  diabetes  make  use  of the  strips  in 
monitors  to measure  their  blood  glucose  levels  and,  if necessary,  adjust  insulin  doses. 
Following  the  extended  recall  in June  1995, the  FDA  found  that  recalled  test  strips 
were  still on pharmacy  shelves  and  available  to the  public.  The  FDA  took  a number 
of actions,  including  mailing  an Urgent  Notice  to all pharmacies  in the  U.S. on 
October  11, 1995.  The  notice  was developed  in collaboration  with the  manufacturer 
and  consequently  reflects  wording  negotiated  between  FDA  and  the  manufacturer. 
The  notice  described  the  test  strip  problem  and  requested  all pharmacies  to remove 
any affected  stock  and  post  an important  public  notice  for  consumers  who may have 
purchased  these  products  previously. 
While  CDRH  was in the  process  of issuing the  Urgent  Notice,  it requested  us to 
closely monitor  the  receipt  of the  notice  and  assess its effectiveness.  We  conducted  a 
nationally  representative  telephone  survey of 279 pharmacies  to get  a broad 
perspective  of how pharmacies  perceived  the  Urgent  Notice  and  a multi-regional  on-
site survey  of 183 pharmacies  to validate  national  information  and  to make  a personal 
examination  of their  test  strip  stock.  A more  detailed  description  of the  methodology 
is found  in Attachment  A. 
FINDINGS 
A  majoriy  of the pharmacists surveyed acknowledged receiving the FDA  Ugent  Notice 
About  Recalled Blood  Glucose  T~t  Strips. One-third or more did not. 
Our  study revealed  that  67 percent  of the  pharmacists  telephoned  and  56 percent  of 
those  visited  acknowledged  receiving  the  Urgent  Notice. 
1
 Discussion.  We  are  unable  to  explain  why  some  pharmacists  did  not  know  about  the

notice.  We  specifically  asked  to  talk  to  the  head  pharmacist  or  other  person  who

should  have  been  made  aware  of an  important  FDA  notice.  One  possibility  is that  the

mail  was  forwarded  to  another  department  in  the  store  or  the  store  manager.

However,  we  have  no  data  to  document  the  prevalence  of this  practice.

Other  possible  explanations  are  that  respondents  had  not  yet  received  the  FDA  notice

at the  time  we conducted  our  surveys, or had  received  it but  forgotten  about  it.  Both

of these  were  minimized  by our  study design.  We waited  10 days after  FDA  had

mailed  the  notice  before  we began  our  surveys, and  completed  them  within  a two

week  period.

Another  possible  explanation  is that  the  mailing  list we used  was different  from  the

one  used  by FDA.  The  FDA  obtained  its list from  a marketing  firm  that  used  the

mailing  list of the  National  Council  for Prescription  Drug  Programs.  We  did not  use

this same  list for two reasons.  Various  logistical  factors,  including  lack  of

computerized  format,  precluded  our  using this list in a timely  fashion,  which was

critical  for  the  evacuation.  Second,  the  list we used  from  the  controlled  substances

registrant  file of pharmacies  maintained  by the  Drug  Enforcement  Administration  was

readily  available  in usable  format.  While  neither  we nor  FDA  believed  the  lists to be

identical,  they both  represent  licensed  pharmacies  and  should  be very similar.  We

were  unable  to make  a detailed  comparison  of the  lists for this study.

Clearly,  more  research  would  be  needed  to determine  exactly why some  of the

pharmacists  we interviewed  did not  acknowledge  receipt  of the  notice.

l%e FDA  Uigent Notice  was the vehicle that made approximately one-hay  of the 
pharmacies  that received it aware of the blood glucose test strip problem. 
Of the  pharmacists  that  acknowledged  receipt,  45 percent  of the  pharmacists 
telephoned  and  58 percent  of the  pharmacists  visited  learned  of the  recalled  glucose 
strips  from  the  Urgent  Notice. 
Of the  remaining  pharmacists  that  did not  receive  the  notice,  only 35 percent  of those 
surveyed  by telephone  and  40 percent  of those  visited  said  they were  previously  aware 
of the  problem. 
lWu7e a majority of pharmacists reprted  checking for  and removtig  affected stock  we 
found  recalled blood glucose strip  in one pharmacy  we Viritetl 
The  FDA  recommended  that  pharmacies  check  their  inventories  and  immediately 
remove  any identified  lot numbers  from  their  shelves.  We  asked  those  pharmacists 
who had  acknowledged  receiving  the  alert  if they  carried  out  this recommendation; 
84 percent  of those  telephoned  and  71 percent  of those  visited  reported  they  had  in 
fact  checked  for and  removed  any recalled  stock.  The  only reason  they  stated  for not 
following  this recommendation  was not  carrying  the  affected  brands. 
2 
  In all our  site visits, regardless  of whether  the  pharmacist  acknowledged  receipt  of the 
notice,  we attempted  to verify that  affected  stock was not  available  for  sale.  We were 
unable  to examine  stock  in all locations,  and  some  pharmacies  did not  carry  the 
affected  brands.  We  did find one  pharmacy  with four  boxes  of recalled  test  strips  on 
their  shelf, which were  promptly  removed  when  brought  to their  attention. 
Discussion.  Based  on the  first two findings  alone  one  might  have  expected  to find 
more  instances  of recalled  product  on the  shelves.  After  all, most  of those  who had 
not  received  the  FDA  notice  were  not  previously  aware  of the  problem. 
One  possible  explanation  is that  recalled  stock  may already  have  been  sold.  The 
manufacturer  sent  out  its first recall  notice  in January  1995, a full 9 months  before 
FDA  sent  out  its Urgent  Notice.  Presumably,  the  distributors  would  have  ceased 
shipping  the  defective  stock  as soon  as they received  the  manufacturers  recall  notice. 
During  the  ensuing  9 months,  any pharmacies  that  were  not  notified  of the  defective 
product  may well have  depleted  their  stock  through  sales. 
Another  possible  explanation  is the  fact  that  the  pharmacies  carrying  this brand  of 
product  are  not  randomly  distributed  across  the  country  like our  phone  sample  was 
nor  concentrated  in the  nine  metropolitan  areas  where  we conducted  our  on-site 
reviews.  It may be  that  the  manufacturers  recall  effectively  reached  most  of the 
pharmacies  which  carry  the  brand.  However,  we must  caution  that  this is pure 
speculation  on our  part.  Our  study was not  designed  to test  the  effectiveness  of the 
manufacturers  recall. 
Few phamuzcies posted  the public notice which FDA  had provided 
The  FDA  also recommended  that  pharmacies  post  an attached  important  public 
notice  about  the  defective  test  strips  where  it would  be visible  to consumers.  We 
found  that,  of the  pharmacies  receiving  the  Urgent  Notice,  only 29 percent  of the 
telephoned  pharmacies  and  13 percent  of the visited  pharmacies  posted  the  public 
notice.  The  pharmacies  not  posting  the  notice  gave the  primary  reasons  as the  brands 
were  not  stocked,  they  did not  realize  they were  supposed  to post  the  public  notice, 
and  they  did not  read  the  Urgent  Notice  thoroughly  enough  to realize  there  was an 
attached  notice.  Comments  offered  by some  of the  pharmacists  indicated  that  they 
did not  understand  the  importance  of posting  the  notice.  They  suggested  that  FDA: 
more  clearly  indicate  the  importance  of posting  it; highlight  the  existence  of the  public 
notice  clearly  at the  front  of the  Urgent  Notice;  and  clarifj  whether  it is necessary  to 
post  a notice  regarding  a product  that  is not  stocked. 
ISSUES  FOR  CONSIDERATION 
Our  study leaves  several  issues unanswered.  FDAs urgent  notice  did reach  many 
pharmacists  that  would  not  have  otherwise  been  aware  of the  defective  product.  Why 
it did not  reach  the  others  is not  evident  from  our  study.  Clearly,  more  research  on 
how to effectively  reach  this kind  of audience  is warranted. 
3  We were  pleased  to be  of assistance  to FDA  in its efforts  to improve  the  urgent 
notification  process.  We  strongly  encourage  CDRH  to continue  in its efforts  to 
improve  notification  of the  health  care  community  on important  safety  issues with 
medical  devices.  Based  on our  review  of this single Urgent  Notice,  we offer  the 
following  issues  for consideration  as CDRH  explores  other  dissemination  methods  and 
evaluates  possible  changes  in format  for notices  and  alerts.  We  recognize  the 
budgetary  constraints  that  exist in piloting  or implementing  any new  options.  As the 
responsibility  of communicating  safety  information  to the  health  care  community  is 
shared  with  other  Centers,  cooperation  and  more  focused  attention  by several  Centers 
may yield  the  best  results. 
l%e FDA  should consider other diwemination tnethodk for  zugent alert informatio~ 
especially for those sztuationswhere complete  dissemination k essential 
The  process  of using first class mail was not  successful  in reaching  the  entire  target 
audience  for this Urgent  Notice.  The  success  of any dissemination  through  mail will 
be  highly dependent  on several  variables,  such as the  accuracy  of the  mailing  list and 
internal  mail  distribution  within  businesses  or offices.  No  doubt,  situations  will 
continue  to arise  where  first  class mail  may  be  the  only  option  available.  Also,  as a 
more  official document  of the  agency, with emblems  and  signatures,  first  class mail 
may always be  useful  as a follow up to other  dissemination  vehicles.  However,  where 
timeliness  or complete  dissemination  is essential,  other  methods  may  provide  more 
reliable,  efficient  means.  These  methods  might  include  telephone,  fax, or electronic 
means,  such  as on-line  systems  used  by claims  processors  or third  party  programs. 
Health  care  professional  groups  and  associations  may be helpful  in identi@ing  or 
creating  networks  for facilitating  dissemination. 
Ilze FDA  should consider r#onnattingjitture  alertr and notices to clarifi the actkms 
healih care profemonalr are recommended  to carry out. 
Not  all those  who  said they had  received  the  notice  carried  out  the  recommendation 
to post  the  consumer  notice.  Comments  from  our  survey indicated  that  some  did not 
see  the  instructions,  perhaps  not  reading  the  notice  completely,  while  others  exercised 
judgment  and  determined  that  it was not  necessary.  For  future  alerts,  clearly  stated 
recommended  actions  may need  to be highlighted  or prominently  placed  to focus 
reader  attention.  These  issues  of clarity  and  format  will also be  relevant  if other 
dissemination  vehicles  are  adopted. 
AGENCY  COMMENTS  AND  OIG  RESPONSE 
We  received  comments  from  FDA  on the  draft  report  and  they  are  included  as 
Attachment  B.  They were  generally  supportive  of the  evaluation  and  results,  and  have 
agreed  to undertake  a broader  review  of the  program,  including  an in-depth  look  at 
new  technologies  for communication.  The  FDA  did disagree  with our  conclusion  in 
the  draft  report  that  first class mail  could  not  be  relied  upon  to reach  all pharmacies. 
We  agree  that  this conclusion  was stated  too broadly.  We  did not  measure  whether 
4  the  notice  was delivered  to pharmacies,  but  rather  examined  whether  the  responsible 
pharmacist  was aware  of the  information  that  had  been  mailed.  We  modified  our 
report  to clarify that  our  conclusion  related  to the  pharmacists,  not  the  pharmacies. 
The  FDA  also provided  a number  of helpful  technical  comments,  and  we have  made 
changes  where  appropriate.  The  FDA  also asked  us for any specific  recommendations 
we might  have  on reformatting  the  urgent  notices  to make  them  more  effective. 
While  we have  our  opinions  on the  matter,  we feel  that  it would  be best  if any 
changes  in reformatting  notices  should  be  considered  as part  of a broader  strategy  and 
developed  by professionals  knowledgeable  in the  communications  field.  At FDAs 
suggestion,  we have  included  copies  of the  Urgent  Notice  (Attachment  C) and  survey 
instruments  (Attachments  D and  E). 
5
 Attachment  A 
METHODOLOGY

We  held  several  discussions  with representatives  of the  CDRH  to determine  the  focus 
of the  study.  We  decided  to assess  the  Urgent  Notice  by conducting  two surveys of 
community  pharmacies  in the  United  States.  Two separate  samples  were  drawn  for 
the  surveys.  The  first sample  was intended  to be  representative  of all pharmacies  in 
the  country.  This  sample  was used  for the  national  telephone  survey to  assess the 
effectiveness  of the  FDA  urgent  notice  by obtaining  a broad  perspective  of how both 
urban  and  rural  pharmacies  throughout  the  country  perceived  the  Urgent  Notice.  The 
second  sample  included  only pharmacies  located  in specified  urban  areas.  This was 
used  for  the  second  survey, which was a regional  on-site  survey, to validate  national 
information  solicited  and  to make  a personal  examination  of their  blood  glucose  test 
strip  stock. 
To  develop  our  sampling  frame  of pharmacies  in the  United  States,  we obtained  the 
Controlled  Substances  Registrant  File  of pharmacies  maintained  by the  Drug 
Enforcement  Administration,  Department  of Justice.  This file contained  the  names 
and  addresses  of 60,970 registered  pharmacies  with a business  activity  code  of A, 
indicating  the  entity  was a pharmacy.  This was the  only source  we used  to obtain 
sample  pharmacies  for  data  collection. 
National  Telephone Survey 
This survey involved  contacting,  by telephone,  a simple  random  sample  of 330 retail 
pharmacies  from  the  list of 60,970.  Based  upon  our  sampling  assumptions,  this  sample 
size would  give us a 90 percent  assurance  that  the  true  proportion  of pharmacies 
recognizing  the  Urgent  Notice  would  be within  five percent  of our  estimate. 
The  actual  number  of pharmacies  completing  the  telephone  survey was 279 or 85 
percent.  There  are various  reasons  why some  pharmacies  did not  complete  the  survey 
which  included  (1) no longer  in business,  (2) non-cooperation  by the  pharmacist,  and 
(3) the  business  was not  a retail  pharmacy. 
R~onal  On-sile Survey 
Using  simple  random  sampling,  we selected  25 pharmacies  in each  of the  following 
metropolitan  areas;  Boston,  New York,  Philadelphia,  Atlanta,  Kansas  City, Chicago, 
Dallas,  San Francisco,  and  Washington  D. C., for a total  of 225 pharmacies.  This 
sample  size was dictated  by resource  constraints  rather  than  desired  precision  levels. 
Any pharmacies  selected  in the  national  sample  that  fell within  the  sampling  frame  of 
any of the  nine  metropolitan  areas  was automatically  included  in  the  regional  sample. 
6
 Of the  225 pharmacies  in the  sample,  the  actual  number  of pharmacies  visited  and 
completing  the  on-site  survey was  183 or 81 percent.  Among  the  reasons  for not 
completing  all the  on-site  visits were  (1) pharmacy  no longer  in business,  (2) business 
was not  a retail  pharmacy,  and  (3) pharmacy  location  was outside  the  area  to be 
visited. 
Both  surveys were  conducted  during  a two week  period  starting  10 days after  FDA 
sent  out  its Urgent  Notice. 
The  questions  used  in both  survey documents  were  identical.  However,  the  on-site 
visits included  examining  the  pharmacies  test  strip  inventory  for the  brands  listed  in 
the  Urgent  Notice  and  any identified  lot numbers. 
The  following  table  provides  our  estimates  of the  standard  errors  and  lower  and  upper 
95 percent  confidence  intervals  for figures  presented  in this report.  Estimates  for the 
local  site visits are  appropriately  weighted  to reflect  the  sampling  design.  only  in the 
case  of posting  the  notice  does  there  appear  to be  a significant  difference  in the 
proportions.  Of those  acknowledging  receiving  the  Urgent  Notice,  29 percent  of those 
contacted  by telephone  claim  to have  posted  the  notice.  Less  than  half  of that 
proportion  made  a similar  claim  among  the  local  site visits,  13 percent.  The 
confidence  intervals  of these  two estimates  do not  overlap. 
Estimates,  Standard  Errors  and  Confidence  Intervals 
for Values  Presented  in Report 
95%  Conf.  Interval 
Est.  Std. Err.  Lower  Urmer 
Proportion  of Pharmacies Receiving  Urgent  Notice 
Telephone  Survey  0.667  0.028  0.612  0.722 
Local  Visit Survey  0.561  0.044  0.475  0.647 
Proportion  Learning of Recall  horn Urgent Notice* 
Telephone  Survey  0.452  0.036  0.381  0.523 
Local  Visit Survey  0.579  0.060  0.461  0.697 
Proportion  Posting Urgent Notice* 
Telephone  Survey  0.290  0.033  0.225  0.355 
Local  Visit Survey  0.130  0.039  0.054  0.206 
*Among  Those  Acknowledging  Receipt  We  conducted  our  review  in accordance  with the  Qzdi~  fhndtm.  for Inspections 
issued by the Presidents  Council on Integrity and Efficiency. 
8 
  Attachment  B 
,+%,
Public Health  Service 
DEPARTMENT OF HEALTH & HUMAN  SERVICES 
Food and  Drug  Administration 
@ 
+,+
.>,,,,O
Memorandum 
3  /  /996 
Date  NAY 
From 
Deputy  Commissioner  for Management  and Systems  (Acting) 
Subject	 Food and Drug Administrations  (FDA) Comments  on the Office of Inspector  Generals 
(OIG) Draft  Report,  FDAs  Urgent  Notice,   (OEI-07-94-00631)  - INFORMATION 
To 
Deputy  Inspector  General  for Evaluation  and Inspections 
We reviewed  the referenced  draft report  and prepared  the attached  comments, 
We are pleased  to report  that FDAs Deputy  Commissioner  for Operations  has agreed to 
conduct  a review  of your reports  suggestions. 
If your staff has any questions,  please  have them contact  Jim Dillon on (301) 443-6392. 
%hmyd
Robert  J. Byrd 
Attachment  COMMENTS  OF  THE  FOOD  AND  DRUG  ADMINISTRATION  ON  THE  OFFICE 
OF  INSPECTOR  GENERAL  (OIG)  DRAFT  REPORT,  FDAS  URGENT  NOTICE, 
0EI-07-94-O0631,  APRIL  9,  1996 
General  Comments 
The  Food  and  Drug  Administration  (FDA)  appreciates  the  opportunity  to  review  and 
comment  on  the  draft  report.  We  acknowledge  the  OIGS  prompt  response  and 
thoughtful  efforts  to our  request  to  evaluate  the  effectiveness  of the  Agencys  October  I I, 
1995  Urgent  Notice  on  recalled  blood  glucose  test strips.  We  believe  the  report  will 
provide  useful  information  to  improve  the  Agencys  Center  for  Devices  and  Radiological 
Healths  (CDRH)  Postmarked Safety  Notification  Program. 
The  FDA  agrees  with  the  OIG  draft  report  that  recognizes  the  tremendous  importance  of 
rapidly  and  accurately  communicating  safety  information  to the  health  care  community. 
The  FDA  also  agrees  that  we  must assure  that  our  outreach  capabilities  are of the  highest 
quality  and  are  received  by the  health  care  community  in a format  that  is maximumly 
useful.  The  OIG  draft  report  serves as a timely  catalyst  for  encouraging  FDA  to 
undertake  a broader  examination  and  to  improve  the  overall  program.  To  this  end,  the 
Deputy  Commissioner  for  Operations  has agreed  to conduct  a prompt  review  of the  OIG 
suggestions,  including  an  indepth  look  at new  technology  (such as electronic 
communications)  and  new  approaches  to  older  technology  (such as reformatting  existing 
alerts  and  notices). 
The  FDA  disagrees  with  the  OIGS  conclusion  that  states FDAs  process  of using  first 
class mail  cannot  be  relied  upon  to  reach  all  pharmacies.  This  conclusion  is based  on 
the  OIGS  finding  that  one-third  or  more  of the  pharmacies  surveyed  did  not 
acknowledge  receiving  the  urgent  notice.    This  finding  is incongruent  with  FDAs  rate 
of  returned  notices.  Of  the  approximately  66,OOO  urgent  notices  sent  to  pharmacies, 
fewer  than  1,000  were  returned  to  FDA  resulting  in a return  rate of  1,5/0.  In addition, 
OIG  gave  FDA  a list of names  and  addresses  of  the  pharmacists  who  stated they  did  not 
receive  the  notice  so that we  could  reissue  it.  The  Agency  did  not  receive  any  returned 
notices  after  they  reissued  them.  As discussed  in  our  technical  comments,  we  asked  OIG 
to  provide  more  explanations  concerning  the  issues addressing  the  acknowledgment  of 
notices.  Since  there  are  many  unanswered  issues, we  believe  more  research  is needed 
before  drawing  a conclusion  concerning  the  use of  first class mail.  Attachment  C 
HFZ-51O 
U.S.  DEPARTMENT  OF
 FIRST  CLASS  MAIL 
tHEA1-TH AND  HUMAN  SERVICES
 POSTAGE  AND  FEES  PAID 
Public  Health  Service
 PHS/FDA 
Food  and  Drug  Administration
 PERMIT  NO.  G-285 
Center  for  Devices  and  Radiological  Health

Rockville,  Maryland  20857

FDA  IMPORTANT  NOTICE

For  Users  of  Blood  G[ucose  Test Strips  IMPORTANT  NOTICE 
FOR  USERS  OF 
BLOOD  GLUCOSE  TEST  STRIPS 
WHATS  THE  PROBLEM? 
Some  brands  of blood  glucose  test  strips  for  use in blood  glucose  meters  may  give 
incorrect  high  or low readings,  leading  to serious  health  problems.  The 
manufacturer  has  recalled  the  product  and  asked  that  these  strips  be taken  off the 
store  shelves,  but some  people  may still  be using  the  recalled  strips. 
HOW  DO  I KNOW  IF  I HAVE  THE  RECALLED  TEST  STRIPS? 
You  must  look  at two things: 
1.  Check  the  brand.  The  following  brands  were  recalled: 
BRJl_E- LIFE  HEALTH  MART  QUICK  CHECK  ONE

BROOKS  LONGS  QUICK  CHECK  3

BROOKS  1  MK (MEDICAL)  RELIEF  PLUS

FAMILY  PHARMACY  PERRY  1  RELIEF  PLUS  ONE

FULL  VALUE  PERRY  HEALTH  CARE  TOP  CARE

GIANT  EAGLE  QUALITEST  3  VALU-RITE

GOOD  NEIGHBOR

2.	 Check  the  lot number  on the  container.  The  recalled  strips  have  lot numbers 
beginning  with  30,  31, 41,  or  43.  These  brands  are  OK if they  have  other  lot 
numbers. 
IF YOU  ARE  USING  BLOOD  GLUCOSE  TEST  STRIPS  THAT  MATCH  THE 
ABOVE  BRANDS  AND  LOT  NUMBERS: 
1.  Stop  using  these  test  strips  and purchase  a fresh  supply. 
2.	 Continue  using  your  blood  glucose  meter  with  your  new test  strips  and  follow 
your  doctors  instructions. 
3.  Contact  your  pharmacist  or doctor  if you  have  concerns  or questions. 
4.	 For  information  on how  to exchange  recalled  test  strips,  call  the  manufacturer  at 
1-800-446-4374  from  8:00  a.m.  to 4:00  p.m.  Pacific  Time  and  11:00  a.m.  to 7:00 
p.m.  Eastern  Time.  Diagnostic  Solutions,  Inc. has  improved  the manufacturing  process  to correct  the 
problem  and  the  company  is now  manufacturing  new strips  under  these  same  brand 
names.  The  new  strips  are  sold  in containers  that  look  almost  identical  to those  in 
which  the  recalled  test  strips  are packaged.  Therefore,  to identify  the  recalled  test 
strips,  it is important  to examine  the  lot numbers, 
OTHER  RECOMMENDED  ACTIONS 
In the  interest  of safety  to patients,  who  may still  have  the  recalled  strips  in their  homes, 
FDA and  the  manufacturer  are also  asking  that: 
  Health  care  facilities  stop  use of the recalled  strips 
	 Health  care  professionals  display  and  disseminate  the  attached 
Important  Notice  and  advise  patients  to discontinue  use  of the  recalled 
test  strips,  and 
	 Organizations  notify  their  members.  (This  document  and  the  attached 
Important  Notice  may  be reproduced.) 
In the  meantime,  FDA will  continue  to monitor  the  effectiveness  of the  recall.  it is 
critical  that- all pharmacies  complete  the  reoall  process  that  the  company  has-initiated 
by following  the  above  recommendations. 
Diagnostic  Solutions,  Inc., will  replace  the recalled  test  strips.  For  more  information, 
call  1-800-446-4374.  This  number  is available  to health  care  professionals  and 
consumers.  The  hours  of operation  are 8:00  a.m. to 4:00  p.m.  Pacific  Time/l  1:00  a.m. 
to 7:00  p.m.  Eastern  Time. 
D. Bruce  Burlington  

Director

Center  for  Devices  and

Radiological  Health
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Food and  Drug  Administration 
Rockville  MD  20857 
October  11,  1995 
URGENT  NOTICE  ABOUT 
RECALLED  BLOOD  GLUCOSE  TEST  STRIPS 
Dear  Health  Care  Professionals: 
A number  of blood  glucose  test  strips  were  recently  recalled  by the  manufacturer 
because  they  may  give  inaccurate  readings,  both  high  and  low, posing  a potentially 
serious  health  risk  to users. 
The  strips  were  recalled  and  a press  release  issued  by the  manufacturer.  However, 
FDA and  the  manufacturer  have  recently  found  recalled  strips  in some  retail  outlets  and 
health  care  facilities,  such  as nursing  homes.  The  recalled  test  strips  may  also  be in 
home  medicine  cabinets. 
Retailers  are  hereby  notified  by FDA  in conjunction  with  Diagnostic  Solutions, 
Inc., that  notifications  concerning  recalled  blood  glucose  test  strips  should  not 
be ignored. 
RECOMMENDED  ACTIONS 
FDA  and  the  manufacturer  are  urging  that  pharmacies  and  health  care  facilities: 
  check  inventories  and  immediately  remove  the  indicated  test  strips 
from  their  shelves,  and 
  post  the  attached  Important  Notice  where  it is visible  to consumers. 
HOW  TO  IDENTIFY  THE  PROBLEM  TEST  STRIPS 
The  recalled  test  strips,  all manufactured  by Diagnostic  Solutions,  Inc.,  were  sold  under 
nineteen  brand  names,  as listed  below.  All the  recalled  test  strips  have  lot numbers 
beginning  with  30,  31, 41,  or 43 and  expiration  dates  ranging  from  February  1993  to 
December  1996.  Other  lot numbers  of these  brands  are  not affected. 
Brand  Names 
BRITE- LIFE  HEALTH  MART  QUICK  CHECK  ONE 
BROOKS  LONGS  QUICK  CHECK  3 
BROOKS  1  MK (MEDICAL)  RELIEF  PLUS 
FAMILY  PHARMACY  PERRY  1  RELIEF  PLUS  ONE 
FULL  VALUE  PERRY  HEALTH  CARE  TOP  CARE 
GIANT  EAGLE  QUALITEST  3  VALU-RITE 
GOOD  NEIGHBOR  Attachment  D 
Office  of  Inspector  General 
Office  of  Evaluation  and  Inspections 
Kansas  City  Regional  Office 
TELEPHONE SURVEY DOCUMENT

FDAs URGENT NOTICE PROCESS

Inspection #OEI-07-94-00631

Pharmacy  Name 
Date 
Pharmacy  Address  Phone# 
Respondent/Pharmacist  Name 
NOTE: You will  need  to  determine  if  the  pharmacist  on  duty 
will  be  able  to  answer  the  questions.  The senior 
pharmacist  or pharmacist-manager  would be preferable;  at a 
minimum,  you should speak with a full-time  (or close to 
full-time) pharmacist who regularly works in that 
pharmacy.  Pharmacists who work part-time  (or p.r.n. or 
on-call basis) or in several pharmacies will probably not 
be the best source of information.  If the only pharmacist 
available  is in this latter category, ask when the senior 
pharmacist  will be available and call back. 
1.	 Did you receive the Urgent Notice about Recalled  Blood

Glucose  Strips issued by FDA on October 11, 1995  (the

title was in bold red letters)?

Yes  No

If no, explain  to  them  that  you  will  advise  FDA so  it  can 
nail  them  the  Urgent  Notice. 
Were you previously  aware of the problem with these 
2.	
glucose strips? 
Yes  No

If yes, when  and  how  did  you  learn  of  the  problem? 
NOTE: IF RESPONDENT  DID NOT RECEIVE THE URGENT NOTICE END

THE INTERVIEW AT THIS POINT.
 3.	 Did you follow the recommendation  in  FDAs  Notice  checking 
your inventory and immediately  removing  the  indicated  test 
strips? 
Yes
 No

If no, why not?

4.	 Did you post the attached important Notice where it was 
visible to consumers? 
Yes  No

If yes, describe where the Notice was posted.

If no, why didnlt you post the important Notice?

5.	 Have you disseminated the important Notice and/or advised 
individuals  to  discontinue  use  of the recalled-test

strips? 
Yes  No

If yes, to whom?

6.  Did the Notice raise questions
 or concerns which required

you to contact FDA?

Yes  No

If yes, what were those questions/concerns?

7.	 Did you think the Urgent Notice was clearly and

understandably  written?

Yes  No

If no, what particular portion of the Notice caused you

problems?

8.	 Do you have any additional comments or suggestions  that

could improve future FDA Notices?

Yes  No

If yes, please explain.
 Attachment  E

Office of Inspector General

Office of Evaluation and Inspections

ON-SITE SURVEY DOCUMENT

FDAs URGENT NOTICE PROCESS

INSPECTION #oEI-07-94-00631

Pharmacy Name  Date

Pharmacy Address  Phone#

Respondent/Pharmacist  Name

Upon entering the pharmacy, ask to see the head pharmacist.

NOTE: You will need to determine if the pharmacist  on duty

will be able to answer the questions.  The senior

pharmacist  or pharmacist-manager  would be preferable;  at a

minimum,  you should speak with a full-time  (or close to

full-time) pharmacist who regularly works  in that

pharmacy.  Pharmacists who work part-time  (or p.r.n. or

on-call basis) or in several pharmacies will probably not

be the best source of information.  If the only pharmacist

available  is in this latter category, ask when the senior

pharmacist  will be available and do a revisit.

1.	 Did you receive the Urgent Notice about Recalled  Blood

Glucose Strips issued by FDA on October  11, 1995?

Yes  No

NOTE: If they did not receive the Urgent Notice provide

them with a copy of the Urgent Notice and the attached

notice to be posted for their review.

If the pharmacy is located in a Csstore,lCask

if it is possible that the sstore~tm
anager  received the

Urgent Notice in the mail and it didntt qet to the

pharmacy?  If the pharmacist believes  this is a strong 
possibility,  ask the tstoresmanager  if he/she did get the

notice.

2.	 Were you previously aware of the problem with the blood

glucose  strips?

Yes  No

If yes, when  and  how  did  you  learn of the problem?  7.	 Did you  think the Urgent Notice was clearly and 
understandably  written? 
Yes  No

If no, what particular portion of the Notice caused you

problems?

8.	 Do you have any additional comments or suggestions  that

could improve future FDA Notices?

Yes  No

If yes, please  explain.