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Last updated: 7th March 2011
First published: 7th March 2011
Article written by Brett M. Christensen
About Brett Christensen and Hoax-Slayer
Boehringer Ingelheim announced a precautionary recall of specific batches of Buscopan 0,1% Syrup 100ml, which is indicated for use in the treatment of conditions associated with gastrointestinal spasm (stomach cramps and colic).However, while such a recall did take place, the information in the version of the warning that is currently circulating is potentially misleading. Firstly, the warning does not include a specific date but suggests that the recall was reported in "today's Beeld" ( Beeld is an Afrikaans language daily newspaper distributed in South Africa). The claim that the message was reported "today" along with the absence of a date may cause many recipients to erroneously assume that the recall is new. As noted above, the recall actually took place in August 2010 and no such recall has been reissued since then. The misconception that the recall has only just been issued may unnecessarily confuse consumers.
The reason for the recall is that a microbial contamination with a bacterium of the Acinetobacter family was detected in certain batches of the product. However, most strains of this bacterium are considered to be nonpathogenic in healthy individuals.
Expert opinion has been obtained from a microbiologist who stated that "oral ingestion of the organism is very unlikely to cause illness".
To date we have not received any serious adverse events from Southern Africa for the respective batches of Buscopan 0,1 % syrup 100ml.
As a responsible pharmaceutical company, Boehringer Ingelheim South Africa, has voluntarily decided to recall these specific batches as a precautionary measure.
The batch numbers being recalled are:
· Lot No. 194A Expiry Date: 10/2011
· Lot No. 201A Expiry Date: 04/2012
· Lot No. 205A Expiry Date: 06/2012
· Lot No. 206A Expiry Date: 06/2012
· Lot No. 207A Expiry Date: 06/2012
Patients in possession of any bottles with the above-mentioned lot numbers (opened or unopened) are requested to immediately refrain from using the product and return the product to their pharmacy for a refund.
The lot number and the expiry date can be located on the top flap of the packaging box and on the bottom right-hand corner of the bottle label.
This recall only applies to the above-mentioned lot numbers.
Statement issued on behalf of Boehringer Ingelheim (Pty) Ltd.
Last updated: 7th March 2011
First published: 7th March 2011
Article written by Brett M. Christensen
About Brett Christensen and Hoax-Slayer