New Delhi: The US-based subsidiaries of two domestic drug firms—Sun Pharma and Cadila Healthcare—are recalling one product each from the market on account of failure to meet the desired specification norms.
Zydus Pharmaceuticals USA Inc is recalling 2,472 units of Bupropion Hydrochloride extended release tablets manufactured by Ahmedabad-based Cadila Healthcare, the latest Enforcement Report of the USFDA has said.
Bupropion Hydrochloride extended-release tablets, USP (XL) 300 mg are being recalled by Zydus Pharmaceuticals USA Inc on account of “failed dissolution specifications: product did not meet dissolution specification at an intermediate time point", it added.
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The ongoing nationwide recall is a class III recall, it added. Bupropion hydrochloride extended-release tablets are indicated for the treatment of major depressive disorder. Sun Pharmaceutical Industries Inc, the US arm of drug major Sun Pharma is recalling 3,26,103 bottles of Kenalog (Triamcinolone Acetonide) spray with spray tube topical Aerosol on account of failed stability specifications.
The class III ongoing recall of the product in the strength of 0.147 mg/g, 15 g bottle, that is a physician sample and not for sale is due to, “low out of specification results for alcohol content," the report said.
Kenalog spray is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. As per the United States Food and Drug Administration (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".