Implementing corrective actions at Goa unit; stopped Digene production at the facility: Abbott

Drug maker Abbott on Thursday said it is implementing corrective actions at its Goa-based facility from where it had produced antacid Digene Gel that was recalled from the market due to non-compliance with manufacturing norms. Earlier this month, regulator DCGI cautioned against the consumption of Digene Gel citing safety concerns even as the drug maker recalled several batches of the medicine manufactured at the Goa facility.

The drug regulatory body also advised doctors and healthcare professionals to carefully prescribe and educate their patients to discontinue the medicine’s use and for reporting of any adverse drug reactions arising due to consumption of the said product.

Goa FDA officials had conducted multiple inspections of the plant after the drug maker announced the recall of the antacid produced at the site and found various lapses of manufacturing norms, including hygiene issues, industry sources said.

“We voluntarily stopped Digene manufacturing at our Goa site upon the receipt of the first complaint, recalled all of the Digene Gel manufactured at the site and immediately began implementing corrective actions,” the drug maker said in a statement.
The letter issued by the Goa FDA and their recent visit to the company’s site is part of the regulatory procedure, it added.

The drug maker is in the process of responding to the drug regulator.