Warning on Toxic Enantiomer Levomethorphan Contaminated API Dextromethorphan Manufactured by Konduskar Laboratories Private Ltd., India

The Food and Drug Administration received an International Drug Alert from the World Health Organization (WHO) involving contaminated Active Pharmaceutical Ingredient (API) Dextromethorphan, manufactured by Konduskar Laboratories Private Limited, India.

The API Dextromethorphan is contaminated with Levomethorphan, a toxic enantiomer.  It has caused several adverse drug reactions, including death.

All drug manufacturers and distributors of Dextomethorphan products are strongly advised to exercise extreme caution by recalling or withdrawing products containing API Dextromethorphan that were sourced from Konduskar Laboratories Private Limited India, or by carefully testing the Dextromethorphan products for the presence of toxic Levomethorphan and if the products meet the specifications approved by the drug regulatory agencies.

For more details, kindly follow the WHO link: http://www.who.int/medicines/publications/drugalerts/drugalertindex/en/index.html.  You may also contact WHO  through This email address is being protected from spambots. You need JavaScript enabled to view it..

For information and strict compliance.  For inquiries, kindly email us at This email address is being protected from spambots. You need JavaScript enabled to view it..

 

Attachments:
Download this file (FMC2013-044.pdf)FMC2013-044.pdf

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