Medicines recalled over Indian plant concerns

A number of medicines available to patients in Ireland are due to be recalled in the coming days over concerns at a manufacturing plant in India.

The move follows the recall of five prescription-only drugs by the Medicines and Healthcare Regulatory Agency (MHRA) in Britain, with a further five over-the-counter medicines being withdrawn by the Indian Wockhardt manufacturing company.

The Irish Medicines Board (IMB) has confirmed it is determining the number of products made by the company that are available here in Ireland, and are preparing for a similar recall in the next few days.

“A number of medicines manufactured by the Wockhardt Chikalthana facility in India are currently authorised in Ireland and the IMB is in the process of determining the level of those products that may be currently marketed here,” said an IMB spokesperson. “Subject to the availability of suitable alternatives for Irish patients, those products that are on the market in Ireland will be recalled.”

The drugs in question are produced for a number of leading British retailers including Superdrug, which operates a number of stores in Ireland. One of the prescription-only drugs recalled is gliclazide, which is used to treat people with type 2 diabetes, while the over-the-counter medicines include Superdrug’s Max Strength Cold & Flu Relief and Ibuprofen.

A Superdrug spokesperson confirmed that none of the drugs recalled from the British market are available in their Irish stores.

Different strength Clarithromycin tablets — commonly used to treat pneumonia, bronchitis and ear, sinus, and throat infections — as well as paracetamol tablets have also been withdrawn from sale.

The manufacturing concerns relate to temperature control and record keeping at the Chikalthana site and led to the withdrawal of the company’s good manufacturing practice certificate.

The IMB stressed any recall would be precautionary.

“Any Wockhardt products imported for the Irish market have been tested upon arrival into the EU and there is no evidence that any of the products are not of the required quality,” according to an IMB spokesperson.