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Sun Pharma, Cadila Healthcare recall products from US market

They are recalling one product each from the market on account of failure to meet the desired specification norms

Press Trust of India  |  New Delhi 

Medicine

The US-based subsidiaries of two domestic drug firms — and Cadila — are recalling one product each from the market on account of failure to meet the desired specification norms.

Zydus Pharmaceuticals Inc is recalling 2,472 units of Bupropion Hydrochloride extended release tablets manufactured by Ahemdabad-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 Inc on account of "Failed Dissolution Specifications: product did not meet dissolution specification at an intermediate time point", it added.

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.

Industries Inc, the US arm of drug major is recalling 326,103 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".

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Sun Pharma, Cadila Healthcare recall products from US market

They are recalling one product each from the market on account of failure to meet the desired specification norms

They are recalling one product each from the market on account of failure to meet the desired specification norms The US-based subsidiaries of two domestic drug firms — and Cadila — are recalling one product each from the market on account of failure to meet the desired specification norms.

Zydus Pharmaceuticals Inc is recalling 2,472 units of Bupropion Hydrochloride extended release tablets manufactured by Ahemdabad-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 Inc on account of "Failed Dissolution Specifications: product did not meet dissolution specification at an intermediate time point", it added.

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.

Industries Inc, the US arm of drug major is recalling 326,103 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".
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Business Standard
177 22

Sun Pharma, Cadila Healthcare recall products from US market

They are recalling one product each from the market on account of failure to meet the desired specification norms

The US-based subsidiaries of two domestic drug firms — and Cadila — are recalling one product each from the market on account of failure to meet the desired specification norms.

Zydus Pharmaceuticals Inc is recalling 2,472 units of Bupropion Hydrochloride extended release tablets manufactured by Ahemdabad-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 Inc on account of "Failed Dissolution Specifications: product did not meet dissolution specification at an intermediate time point", it added.

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.

Industries Inc, the US arm of drug major is recalling 326,103 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".

image
Business Standard
177 22