Wockhardt to recall drugs from plants with US import alert

Shares tank around 7% on the BSE; stock had closed 18% down yesterday

The Mumbai-based Wockhardt is recalling the remaining batches of drugs in the US that were made before the Food and Drug Administration (FDA) there issued import alerts on its Waluj and Chikalthana plants in Maharashtra. The company said US patients currently using these drugs were at no risk. It is recalling 13 drugs from the US.

Following the announcement on Tuesday, Wockhardt shares fell 11 per cent in intraday trade and closed at Rs 1,243 apiece, down 6.52 per cent on the BSE exchange. On Monday, the share had dropped 18.31 per cent to close at Rs 1,330.05 on BSE.

 

Wockhardt informed BSE some observations were reported pertaining to batches of some products manufactured before the import alerts were issued during the last US FDA inspection of the the L1-Chikalthana and Waluj plants in Aurangabad.

“As a measure of preparedness and as an abundant precaution, the company has now decided to recall, as part of remedial measure, all the remaining batches (of drugs) 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,” Wockhardt said.

Wockhardt’s L1 Chikalthana plant makes the Metoprolol XR drug used for treating blood pressure, while the Waluj one makes injectables and solid dosages. Both have been under the US FDA’s lens since 2013.

“The company continues to supply some of the products in the US market manufactured in the same facilities, while several batches of other products, manufactured prior to the import alerts may still be in the US market,” a company statement said.

In November 2013, US FDA had issued an alert against the Chikalthana plant after it was found to have failed to comply with good manufacturing practice. The American regulator had imposed a ban on the company’s Waluj plant, after inspectors found torn data records in a waste heap, as well as urinals that emptied into an open drain in a bathroom, six metres from the entrance to a sterile manufacturing area.

Following the import alerts, Wockhardt’s US business had declined 56.3 per cent in the second quarter of 2014-15, contributing 24 per cent to the company’s global revenues. For the quarter ended September 2014, Wockhardt posted a decline of 97 per cent in its consolidated net profit at Rs 3.63 crore, because of lower sales and tax expenses. However, it posted a growth of 14 per cent in its net profit for the quarter ended December.