Medications withdrawn over India plant concerns

A number of commonly used medications have been withdrawn from pharmacies over concerns at an Indian manufacturing facility.

All in-date batches of the products have been recalled by the Irish Medicines Board (IMB) following what the board refers to as “a number of significant non-compliances” with best manufacturing practice at the Wockhardt plant in Chikalthana, India.

Three Irish-authorised products and a further 10 unlicensed medicines supplied to Irish pharmacies have been withdrawn. These include medicines commonly used to treat depression, high blood pressure and heart failure.

The recall is a purely precautionary move and patients should continue to take the medicines as prescribed, say the IMB.

“The products on the Irish market have been tested upon their importation into the EU and there is no evidence that any of the products are sub-standard,” said an IMB statement.

“There is also no evidence of any risk to patient safety as a result of the manufacturing issues that have been identified, and it is important that patients continue to take their medicines as prescribed.”

The move follows a similar recall of five-prescription only drugs by the Medicines and Healthcare Regulatory Agency in Britain, with a further five over-the counter medicines withdrawn by the Indian manufacturing firm.

Question marks now linger over three of the manufacturer’s facilities as the UK Medicines Board has since revoked the quality compliance certificate of another Wockhardt factory in India, and the US Food and Drug Administration brought sanctions against a third facility.

The US authorities found hygiene and other compliance deficiencies at the plant in Waluj, India, while the Irish recall is based on temperature control and record keeping concerns in the manufacturing process.

Drug recall

Irish-authorised products:

* KIRNOM XL 400 micrograms prolonged-release hard capsules (Tamsulosin HCl)

* TONPULAR XL 75mg prolonged-release hard capsules (Venlafaxine HCl)

* TONPULAR XL 150mg prolonged-release hard capsules (Venlafaxine HCl)