NEW DELHI :
Macleods Pharmaceuticals has recalled 31,968 bottles of pioglitazone hydrochloride in the US market after the tablets were found to be ‘superpotent’, according to an enforcement report by the US Food and Drug Administration (FDA). Pioglitazone hydrochloride tablets are used to control high blood sugar in type 2 diabetes patients. The tablets were manufactured at the company’s facility at Baddi in Himachal Pradesh.
The class II recall was voluntarily initiated by the company’s subsidiary Macleods Pharma USA Inc on 23 September. A class II recall is initiated in a situation where use of a violative product may cause temporary or medically reversible adverse health issues.
The tablets were shipped to eight distributors who may have further distributed the product, according to information by the US FDA.
Macleods Pharma sells pioglitazone hydrochloride tablets under the brand Actos in dosages of 15 mg, 30 mg and 45 mg, according to information on the company’s website. The recall was for 15-mg tablets.
Macleods Pharma has two formulations manufacturing plants--one at Baddi and the other at Daman--and also has an active pharmaceutical ingredients manufacturing facility at Sarigam in Gujarat.