09/08/2015 // JusticeNewsFlash // (press release)
India – Two major pharmaceutical companies headquartered in Mumbai have issued recalls for drugs in the U.S. market. Business Today reported that the companies separately enacted the recalls for multiple lots of two drugs for varied reasons.
Sun Pharmaceuticals recalled Bupropion Hydrochloride Extended-release Tablets USP (SR) sold in a 200 mg, 60-count bottle over “failed dissolution specification.” Wockhardt voluntarily recalled its Lisinopril Tablets USP sold in 5 mg and 20 mg reportedly over “CGMP violations.”
A notification issued by the U.S. Food and Drug Administration said that the recall by Sun Pharma was initiated under Class-III classification, which is “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”
As many as 35,235 bottles of the 60 count bottles of Bupropion Hydrochloride have been included in the recall. The drug is an antidepressant used for the treatment of major depressive disorder as well as seasonal affective disorder.
The recall of Lisinopril involves more than 5,000 bottles combined of the 1,000 count tablets in 5 and 20 mg. According to the FDA, the recall was listed under class-II classification.
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Source: Business Today News Story Link: http://www.businesstoday.in/sectors/pharma/sun-pharma-wockhardt-recall-drugs-from-us-market/story/223229.html