Wockhardt voluntarily recalls 12 drugs manufactured in its two Indian facilities, Chikalthana and Waluj from US market
Wockhardt on 29 April, 2015 has decided to voluntarily recall its products manufactured in its two Indian facilities, Chikalthana and Waluj facilities from US market. Wockhardt said the US FDA found the company’s quality and manufacturing system satisfactory, but had put forth certain observations on Form 483 pertaining to review of products manufactured before implementation of the GMP remediation programme. So, Wockhardt has decided to voluntarily recall all the remaining batches of 12-15 products that were manufactured in the Chikalthana and Waluj facilities prior to the import alert imposed by the US Food and Drug Administration (US FDA).
Habil Khorakiwala, founder chairman, Wockhardt said "We were looking at the work load involved to deal with this and the time it may take. After the last visit, we evaluated all this, and we thought it would be more prudent to just take a voluntary recall decision across all the products which were in the market before the alert".
Wockhardt officials said "Recall was a measure of preparedness and abundant precaution and there is no evidence of risk to patient safety from these products that are currently available in the US market".