Wockhardt said this 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
Wockhardt on Tuesday said it 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).
Wockhardt said this 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.
“Our main objective was to get back to normalcy faster”, said Habil Khorakiwala, founder chairman, Wockhardt. Khorakiwala said during the last inspection the US FDA had inquired about products that were already in the US market, but had not directed the company to withdraw these products from the market.
“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 there (in the market) before the alert,” Khorakiwala added.
Khorakiwala said the company is yet to assess the range of products involved, but it said it did not expect a very significant financial impact arising out of the recall of these product batches from the US market.
On March 18, Wockhardt had informed the BSE about US FDA’s follow-up inspection of the Chikalthana facility to assess the progress made in areas of good manufacturing practices (GMP) remediation and robust quality management. Wockhardt had 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.
Comments are closed.