Wockhardt recalls drugs on FDA concerns

Drug manufacturer Wockhardt on Tuesday said it is recalling about 12-15 drugs from the US markets produced at its Chikalthana and Waluj units before the facilities were hit by the US Food and Drug Administration (FDA) import alert in 2013.

The US drug regulator had conducted an inspection of both plants earlier this year, following which it made some "observations" regarding batches of some drugs that were made at the plants when they were not banned, Wockhardt said in a statement.

"Several batches" of products produced at the plants before the bans were imposed "may still be" selling in the US, the company said.

Shares of the company tanked 11.26% on the BSE on Tuesday before closing at Rs 1,243.35 per share, 6.52% down over the previous close on concerns that the recall could be due to some directives from the FDA.

Wockhardt chairman Habil Khorakiwala, however, told reporters that the recall was a voluntary decision and there was no directive from the US regulator.

In a BSE filing, Wockhardt said, "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."

Khorakiwala said, "Our objective was to come back to normalcy faster, and FDA was enquiring on how are we going to deal with products that were already there in the market before the alert. So we were looking at workload involved in the issues and the time it may take. After their last visit, we evaluated all these and we felt that it would be more prudent to just take a voluntary decision across all products which were there before the alert."

He said the UK Medicines and Healthcare Regulatory Agency (MHRA) has earlier asked the company to withdraw products from their market. "Both FDA and MHRA are working together, and so we thought it would be better to remain consistent with both the regulators," he said.

Khorakiwala said the withdrawal of products would not have significant financial implication. He said the 12-15 products that would be taken off are available at the wholesale and retail level in the US market. However, post recall, there were a few drugs that were allowed to be manufactured by the US drug regulator, and they are not on the recall lists of drugs.

The company also said that the UK's health regulator, MHRA has restored the EU GMP certification of the company's potent product facility at Kadaiya, Daman. Khorakiwala said as far as the UK authorities are concerned, all facilities are now in compliance.