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 gastro-intestinal spasm (stomach cramps and colic).
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 beingrecalled 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.