According to a notification by the FDA, the recall of 26,530 units of 30-count bottles and 14,597 units of 90-count bottles is voluntarily initiated by the company through a letter to the regulator last month under 'Class-II' classification.
Caraco Pharmaceutical Laboratories, a subsidiary of Sun Pharma , has initiated recall of some lots of Venlafaxine Hydrochloride extended-release tablets from the US market.
According to a notification by the FDA, the recall of 26,530 units of 30-count bottles and 14,597 units of 90-count bottles is voluntarily initiated by the company through a letter to the regulator last month under 'Class-II' classification.
Venlafaxine Hydrochloride extended-release tablets are indicated for the treatment of major depressive disorder. "Stability results found the product did not meet the drug release dissolution specifications," the regulator's website said.
Tablet dissolution is a standardised method for measuring the rate of drug release from a dosage form. The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories Ltd in USA, while manufactured at Halol plant in Gujarat by Sun Pharmaceutical Industries Ltd.
According to the US health regulator, Class II recall is a situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Sun Pharma stock price
On May 16, 2014, Sun Pharmaceutical Industries closed at Rs 616.15, down Rs 5.65, or 0.91 percent. The 52-week high of the share was Rs 653.10 and the 52-week low was Rs 458.00.
The company's trailing 12-month (TTM) EPS was at Rs 1.45 per share as per the quarter ended March 2014. The stock's price-to-earnings (P/E) ratio was 424.93. The latest book value of the company is Rs 41.64 per share. At current value, the price-to-book value of the company is 14.80.
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