25 November 2003
Dear
Head of Obstetrics,
Head of Nursing,
Chief Pharmacist,
URGENT MEDICINE RECALL
SYNTOCINON (oxytocin) 10IU AMPOULES 5 x 1mL
Batch Numbers: S90900 Expiry date: 06/2007
Batch Numbers: S90500 Expiry Date: 05/2007
AUST R 13383
Novartis Pharmaceuticals Australia Pty Ltd wishes to advise that the
quality of 2 specific batches of Synctocinon (numbers S90900 and S90500)
may be sub-optimal. Although this is not yet confirmed, please note the
following:
. These particular batches may be ineffective as a treatment for
post-partum haemorrhage or augmenting labour.
. Novartis strongly recommends that syntocinon from these
particular batches NOT BE USED in any clinical setting. (Testing is
currently underway to determine if there is indeed a problem with this
batch).
. There is NO INDICATION THAT ANY OTHER BATCH OR STRENGTH OF
SYNCTOCINON IS AFFECTED, and so continued use of syntocinon (from other
batches) is appropriate where clinically indicated.
Novartis Australia would like to assure you that the quality of our
products and patient safety are our utmost priorities. We are doing
everything we can to expedite resolution of this situation, and will
inform you of more details as soon as they are available.
In accordance with the Uniform Recall Procedure for Therapeutic Goods
(URPTG), and after consultation with the Therapeutic Goods
Administration, Novartis is voluntarily recalling the above batches of
SYNTOCINON. No other batches are affected by this recall.
Guidance on Returning Stock: Please follow all steps
. Identify the batch number which is displayed on the rear side
panel of the carton, in white on a blue background
. Quarantine the units of the above batch of product immediately
. Complete and return the accompanying Facsimile Reply Form to
Novartis at (02) 9805 1330, even if you have no stock that is subject to
this recall
. Return all units from the batch to your wholesaler who will
return the stock to Novartis
. Your wholesaler will arrange for replacement stock or credit to
be issued to you
. Please retain this letter in a prominent position for one month
in case stock is in transit.
CONTACT NUMBERS
For logistic questions (return of stock, replacement stock etc), please
call NOVARTIS LOGISTICS on 1800 064 713.
For clinical questions, or to report adverse events please call NOVARTIS
MEDICAL INFORMATION on 1800 671 203.
Yours sincerely
Dr. Peter Stewart
Jacqueline McCarthy
Senior Medical Adviser Quality
Assurance Manager
Facsimile Reply Form
To: Novartis Pharmaceuticals Australia Pty Ltd
Attention: Jacqueline McCarthy
Facsimile No.: (02) 9878 1473
Number of Pages 1 including cover page
Date 25 November 2003
Concerning Recall of SYNTOCINON (oxytocin) 10IU AMPOULES 5 x 1mL
Batch Numbers: S90900 Expiry date: 06/2007
Batch Numbers: S90500 Expiry Date: 05/2007
From:
(Name of Institution)
Contact Persons:
(please print)
Telephone No.:
Facsimile No.:
. We DO have stock which is subject to this recall
0
. We DO NOT have stock which is subject to this recall
0
. Unused stock subject to recall (currently in
quarantine):
Batch: S90900 Quantity:
_______________
Batch: S90500 Quantity:
_______________
. Any other relevant details:
___________________________________________
__________________________________________________________________
__________________________________________________________________
Signature: ______________________________
Date: ______________________________
-----Original Message-----
From: [EMAIL PROTECTED]
[mailto:[EMAIL PROTECTED] On Behalf Of JoFromOz
Sent: Friday, 12 December 2003 6:13 AM
To: [EMAIL PROTECTED]
Subject: Re: [ozmidwifery] 3rd Stage Feedback
We had ours recalled. Used 2x 5IU synto instead.
Jo
Robbie Moon wrote:
> bodgy synto? Hmm that's interesting. The hospital where i work has
> had an appalling number of pph's recently also. We were counting
> about 2 a week in the vicinity of 2-3 litres. I've never seen
> anything like it.
> If what you say is true, then it can surely only be the active
> management that precipitates it.
>
> how did you find out it was bodgy?
>
> Robin
>
>
>
>> Ross W Timbs <[EMAIL PROTECTED]> wrote:
>>
>> Denise
>>
>> Yes. At the hospital where I work all the women are public - no
>> private at all. Nearly all women go through midwives' clinic & see
>> the same midwife throughout the pregnancy. Third stage is discussed
>> with all of them, and they are given a pamphlet that lists the pros &
>> cons of active & physiological.
>> A lot of women opt for physiologic - but the majority probably still
>> choose active management.
>> As an interesting aside, we went through a patch a while back where
>> we had an unusually large number of PPHs. Just found out recently
>> that we had a bodgy batch of syntocinon. Perhaps it was the CCT
>> that was used with the ineffective synto that caused these PPHs.
>> Another point in favour of physiologic 3rd stage!
>>
>> Jacky
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