Increased vigilance is requested for batches of Dextromethorphan Active Pharmaceutical Ingredient produced by Konduskar Laboratories Private Limited, Kolhapur, Maharashtra India
On the 23rd November 2012, a serious incident occurred in Lahore, Pakistan which resulted in the death of approximately 20 persons and a number of other serious adverse reactions. All of those affected had consumed a cough syrup with the brand name Tyno, 120ml, locally produced by Reko Pharmacal with Dextromethorphan as the principal active pharmaceutical ingredient.
A second incident occurred on the 26/27 December 2012 when another 40 deaths occurred in Gujrunwala, (70kms North of Lahore), Pakistan. Again all of those affected had recently consumed a cough syrup with the name Dextromethorphan, 120ml, locally produced by Ethical Laboratories, Lahore.
More information is available here.
This Drug alert is issued as a precautionary announcement and a preventative measure in the event that batches of this API may have been widely exported and distributed. In addition, vigilance regarding quality of dextromethorphan as an active pharmaceutical ingredient in general is also recommended.
Further investigations are on-going. Updates will be issued as further information emerges.
If your Country has imported batches of Dextromethorphan active pharmaceutical ingredient manufactured by Konduskar Laboratories, Kolhapur, India, please ensure that it is tested and meets the recognised published specifications.
For any questions relating to this alert please, contact rapidalert@who.int.