Unichem, Macleods Pharma recall drugs from US market
The reason for the voluntary ongoing nationwide is "failed impurities/degredation specifications.
New Delhi: Drug firms Unichem Pharmaceuticals and Macleods Pharma are recalling various lots of tablets used for the treatment of high blood pressure and diabetes from the US market, according to the latest enforcement report of the American health regulator. Unichem Pharmaceuticals USA Inc is recalling 1.91 crore units of Clonidine Hydrochloride tablets used for treating high blood pressure from the US market, the report said.
The company is recalling units of Clonidine Hydrochloride Tablets, USP 0.1 mg manufactured by Unichem Laboratories Ltd at Goa facility, it added.
The reason for the voluntary ongoing nationwide is "failed impurities/degredation specifications. This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into the product from container label, the United States Food and Drug Administration (USFDA) said.
On the other hand, Macleods Pharma USA Inc is recalling 4,694 bottles of Pioglitazone and Metformin Hydrochloride tablets used to treat high blood sugar levels caused by type 2 diabetes from the US market.
The company is recalling Pioglitazone and Metformin Hydrochloride tablets USP 15 mg/500 mg, manufactured by Macleods Pharmaceuticals Ltd at its Baddi facility in Himachal Pradesh, the report said.
The reason for the voluntary nationwide ongoing recall is on account of it being "sub potent drug: out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride tablets," the USFDA said.
Both the recalls by the companies are class III recalls, it added.
As per the USFDA, a class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".