Class 1 drug alert (patient level recall): Counterfeit parallel distributed product
Zyprexa Tablets 10mg (olanzapine)
CLASS 1 MEDICINES RECALL
Action now -
including out of hours
Parallel Distributed Product
The MHRA in
conjunction with the EMEA, with
assistance from Eli Lilly and Company Ltd are
recalling any parallel distributed
stock of Lots A200127, A216454 and A229505
(and lot variants) of Olanzapine
tablets 10mg branded as Zyprexa following the
discovery of counterfeit tablets
in the legitimate supply chain. Please read
the comments below about lot number
variants used in the parallel distribution
This counterfeit material was supplied in
French livery via parallel
distributors into the UK supply chain. Both
genuine Lilly manufactured product
and counterfeit product may be present in the
UK supply chain. Stock presenting
a patient risk may be present as French
livery cartons with an overlabel applied
by a parallel distributor or has been
recartoned into an English carton by the
parallel distribution repacking process.
All the above lots are genuine Lilly lot
numbers for which the original lots
were all supplied to France in French livery.
Please note that Lilly routinely
supply stock to the UK market which is
not parallel distributed and is in UK Lilly
livery. This stock is not affected.
None of this stock has the above lot numbers
We have limited information about this
problem and understand the EMEA has
allowed nearly 40 UK parallel distributors to
supply this product.
Please be aware of the following issues
concerning lot numbers:-
1. Parallel distribution companies may
have added a prefix or suffix to the lot
number, such as A200127/1 to differentiate
different packing runs. These lot
number variants are included in the scope of
2. Parallel distribution companies may
occasionally use a completely different
lot number on the carton. If
the lot number on the
carton is not in the format 'AXXXXXX or
AXXXXXX/X' recipients are advised to
contact the parallel distributor listed on
the carton for clarification.
We intend to provide updated data on
this area if we receive additional
Recipients are asked to attempt to
recover tablets from patients,
quarantine all remaining stock and return as
We request that all stock of the attached lot
number and variants be returned to
Eli Lilly for examination and suggest you
keep full details of any returns.
Please telephone the Customer
Services Team at Eli Lilly on 0800 032
0741 to make arrangements for return.
The issue of reimbursement should be
discussed with your original supplier and
we suggest you keep full records.
Please do not return stock to your original
supplier but contact Eli Lilly as
mentioned above. Your cooperation is
requested in this matter as it will provide
useful information about the origins and
scope of the problem.
Additional information is available in the
FAQs sheet attached.
Primary Care Trusts are asked to bring this
information to the attention of
Community Pharmacists and professionals with
an interest in mental health by
copy of this letter.
MHRA DMRC Manager
Why has a Class
1 Drug Alert been issued in this
Initial tests show that samples only contain
about 60% of the labelled active
ingredient. In addition, a counterfeit is
likely to show a different
bioavailability profile and may contain
harmful degradants. Work is ongoing to
obtain more information but in the interim we
consider a recall is needed to
minimise patient risk.
Why are both French cartons and some
in English livery used?
In some cases the parallel
distributor buys the product in small
cartons and applies their own label. In other
cases the distributor buys the
product in large cartons and packs down into
smaller amounts in their own
Why cannot you be more specific about
the lot numbers used?
It is the decision of the parallel
distribution company whether they
use a prefix, suffix or completely different
lot number. We expect that most
will use a prefix or suffix but cannot rule
out the use of a completely
different number on the carton We
believe that waiting for a full answer from
nearly 40 companies would provide an
unacceptable delay to the Drug Alert.
Why have you requested that all stock
goes to Lilly for examination?
Although there are visual
differences between genuine and counterfeit
stock some are subtle and we do not feel that
recipients should be asked to do
this work. In addition, we need to obtain as
much information as possible about
What is the difference between
parallel distribution and parallel
Parallel traded products are often
sold at lower prices in the EU and
are allowed to be imported and relabelled for
sale in the UK. Parallel
distributed products have a marketing
authorisation issued by the EMEA and
parallel imported products have a marketing
authorisation issued by the MHRA.
In both cases the repacking and relabelling
are inspected by the MHRA but the
importation and/or distribution takes place
outside the original manufacturer's
Are there any differences between the
supply of these lots?
We have no evidence that lot A229505
reached the patient but with lots
A200127 and A216454 there is some evidence
that product has reached the patient.
We request your cooperation in checking to
the same extent for all three lots
due to the serious nature of the problem.
(further recipients by cascade):
Regional Contacts for
NHS Trusts and Provider Units
About The SafeMeds Alert System
Chief Pharmacists: England, Scotland, Wales,
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey,
Alderney, Sark, Isle of Man, Gibraltar
Healthcare Commission for distribution to
Independent Health Care Establishments
Primary Care Trusts (England)
The SafeMeds Alert System is a counterfeit alert
distribution service of the the Partnership
Medicines--a group of
organizations and individuals that have policies,
procedures, or programs to protect consumers from
counterfeit or contraband medicines.