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| Updated on April 28, 2015 Published on April 28, 2015

Wockhardt Ltd has informed BSE that During the last US FDA cGMP inspection of the facilities at L1- Chikalthana and Waluj in Aurangabad, Maharashtra, some observations were reported pertaining to batches of some products manufactured prior to the US FDA Import Alerts.

Whereas the Company continues to supply some of the products in the US market manufactured in the same facilities, several batches of other products, manufactured prior to the Import Alerts may still be in the US market.

As a measure of preparedness and as an abundant precaution, the Company has now decided to recall, as a part of remedial measure all the remaining batches in the US market that were manufactured prior to the US FDA Import Alerts even though there is no evidence of risk to patient safety from the products currently available in the US market.

Additionally, the MHRA, UK has restored the EU GMP certification of the Companys potent product facility at Kadaiya, Daman.

Source : BSE - >www.bseindia.com

Published on April 28, 2015
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