UK health regulator initiates recall of 5 Wockhardt drugs

British health regulator MHRA today initiated recall of five prescription medicines of India's Wockhardt, following manufacturing deficiencies identified during an inspection of the company's site in Chikalthana in Maharashtra.

This follows a precautionary recall by Wockhardt Ltd, which is asking retail outlets to return five over-the-counter medicines, MHRA said in a statement.

"Ten prescription-only medicines can continue to be made at the Chikalthana site and can still be supplied to patients in the UK,"  Medicines and Healthcare Products Regulatory Agency (MHRA) added.

This is because, due to concerns over the continuity of supply, the benefits to patients of continuing to take these medicines outweigh the risk from any quality concerns with the medicine, MHRA said.

When contacted Wockhardt Chairman Habil Khorakiwala told PTI: "We are moving forward to comply with MHRA requirements and we should be doing it quite soon."
Wockhardt in a filing to BSE said: "The agency (MHRA) has issued a Drug Alert for recall of certain products, one time impact of which is expected to be approximately 1 million pounds."

The MHRA said the medicines affected by the recall are in most cases available from alternative manufacturers and the Department of Health will closely work with them to help ensure that patients can get their medicines when they need them.

Commenting on the recall, MHRA's Director of Inspection, Enforcement and Standards, Gerald Heddell said: "People can be reassured that there is no evidence of a safety risk from the medicines made at Wockhardt's Chikalthana site so it's important people to continue to take their medicines as prescribed."

"The company has received another communication from the said agency whereby they have allowed the company to manufacture and supply certain products assessed to be critical to public health," the filing said.

The approximate revenue from these products is 3 million pounds from the UK & EU markets to the consolidated revenues of the company, it added.

The regulator said most of the medicines affected by the precautionary recall are used for pain relief but it also includes one medicine used to treat Type 2 diabetes (Gliclazide).

People do not need to return their medicines because there is no evidence that the medicines affected by the precautionary recall in the UK are defective, MHRA said.
The manufacturing deficiencies identified by the MHRA during the inspection of Wockhardt's Chikalthana site in July 2013 included, poor record keeping relating to the manufacture and testing of the medicines made at the site, inadequate validation and production controls for medicines.

MHRA is working with Wockhardt and other international regulators to resolve this, it added.