Macleods Pharma USA Inc is recalling 31,968 bottles of Pioglitazone Hydrochloride tablets used for treatment of diabetes in the American market.
The tablets being recalled are in the strength of 15 mg and
have been manufactured by Macleods Pharmaceuticals Ltd in its Baddi facility in Himachal Pradesh, an enforcement report of the USFDA said.
The voluntary ongoing class II recall is on account of the product being "superpotent'', it added.
The product was shipped to 8 distributors who may have further distributed the product, the United States Food and Drug Administration (USFDA) said.
As per the USFDA, a class II recall is initiated in a situation, "in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".
The tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.
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