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".
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 (USFDA).
As per information available on the USFDA 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. The group's operations range from active pharmaceutical ingredients (API) to formulations, animal health products and cosmeceuticals.
Cadila Healthcare shares today closed at Rs 1,586 a piece on the BSE, down 1.34 percent from its previous close.
Cadila Health stock price
On December 08, 2014, Cadila Healthcare closed at Rs 1586.00, down Rs 27, or 1.67 percent. The 52-week high of the share was Rs 1760.00 and the 52-week low was Rs 723.10.
The company's trailing 12-month (TTM) EPS was at Rs 47.60 per share as per the quarter ended March 2014. The stock's price-to-earnings (P/E) ratio was 33.32. The latest book value of the company is Rs 177.28 per share. At current value, the price-to-book value of the company is 8.95.
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