New Delhi: Cadila Healthcare is voluntarily recalling 15,144 bottles of its anti-hypertension drug Amlodipine Besylate tablets in the US market, according to the US Food and Drug Administration (FDA).
As per information available on the US health regulator's website, Zydus Pharmaceuticals USA Inc, the US-based arm of the company, is recalling the drug due to "discoloration".
"Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg," the US health regulator said.
The nationwide recall has been initiated by the company on October 1 this year and has been initiated under Class-III which FDA defined as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences".
Comments from the company could not be obtained immediately.
The tablets, which are indicated for the treatment of hypertension, to lower blood pressure, were manufactured by Cadila Healthcare and distributed by Zydus Pharmaceuticals USA Inc.
Headquartered in Ahmedabad, Zydus Cadila group has global operations USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets. Its operations range from active pharmaceutical ingredients (API) to formulations, animal health products and cosmeceuticals.
Shares in Cadila Healthcare, on Monday, ended at Rs 1,586 apiece on the BSE, down 1.34 per cent from the previous close.
New Delhi: Cadila Healthcare is voluntarily recalling 15,144 bottles of its anti-hypertension drug Amlodipine Besylate tablets in the US market, according to the US Food and Drug Administration (FDA).
As per information available on the US health regulator's website, Zydus Pharmaceuticals USA Inc, the US-based arm of the company, is recalling the drug due to "discoloration".
"Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg," the US health regulator said.
The nationwide recall has been initiated by the company on October 1 this year and has been initiated under Class-III which FDA defined as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences".
Comments from the company could not be obtained immediately.
The tablets, which are indicated for the treatment of hypertension, to lower blood pressure, were manufactured by Cadila Healthcare and distributed by Zydus Pharmaceuticals USA Inc.
Headquartered in Ahmedabad, Zydus Cadila group has global operations USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets. Its operations range from active pharmaceutical ingredients (API) to formulations, animal health products and cosmeceuticals.
Shares in Cadila Healthcare, on Monday, ended at Rs 1,586 apiece on the BSE, down 1.34 per cent from the previous close.
New Delhi: Cadila Healthcare is voluntarily recalling 15,144 bottles of its anti-hypertension drug Amlodipine Besylate tablets in the US market, according to the US Food and Drug Administration (FDA).
As per information available on the US health regulator's website, Zydus Pharmaceuticals USA Inc, the US-based arm of the company, is recalling the drug due to "discoloration".
"Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg," the US health regulator said.
The nationwide recall has been initiated by the company on October 1 this year and has been initiated under Class-III which FDA defined as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences".
Comments from the company could not be obtained immediately.
The tablets, which are indicated for the treatment of hypertension, to lower blood pressure, were manufactured by Cadila Healthcare and distributed by Zydus Pharmaceuticals USA Inc.
Headquartered in Ahmedabad, Zydus Cadila group has global operations USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets. Its operations range from active pharmaceutical ingredients (API) to formulations, animal health products and cosmeceuticals.
Shares in Cadila Healthcare, on Monday, ended at Rs 1,586 apiece on the BSE, down 1.34 per cent from the previous close.
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