After multiple plaints, FDA bars sale of antacid Digene
The directive comes after the Drug Controller General of India (DCGI) on August 31 issued an alert to discontinue the use of the antacid gel due to safety concerns
The Food and Drug Administration (FDA) of Pune region has started inspection of chemists in the district selling antacid Digene gel manufactured by Abbott Company. The drug authorities have asked the chemist to stop the sale of the gel manufactured at the Goa plant of the company.
The directive comes after the Drug Controller General of India (DCGI) on August 31 issued an alert to discontinue the use of the antacid gel due to safety concerns. Abbott is voluntarily recalling Digene Gel antacid medicine manufactured at their Goa site due to isolated customer complaints on the gel colour being different, bitter in taste with a pungent odour, said the officials.
S V Pratapwar, joint commissioner, FDA, Pune region, said, the authorities have asked the Chemist Association Pune District (CAPD) to immediately cease the sale of Digene gel.
“The chemists have been asked to recall the stock of medicines. Wholesalers and distributors have been asked to remove the impacted products from distribution. We are keeping a strict eye on movement, sale and distribution of the said drug products,” he said.
Pratapwar, further said the problem is claimed to be in five batches of the medicines and the company has recalled all the stock manufactured at Goa plant.
“The samples of the medicines from the circulation chain will be taken and sent to the lab. Necessary action will be taken if we find anyone violating the norms or in case of quality issues in the samples,” he said.
Vivek Tapkir, CAPD vice-president said, as a precaution the association has asked the members to recall the orders.
“The patients should wait until the central authorities and state FDA give a go-ahead to issue the specific medicine. The stock of the medicines is still available in circulation, but the association will follow the orders of drug authorities,” he said.