US-based Jubilant Cadista recalls over 5,700 bottles of anti-depressant drug from US market
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US-based Jubilant Cadista Pharmaceuticals is recalling over 5,700 bottles of Bupropion Hydrochloride extended-release tablets, used to treat major depressive disorder, from the US market. The company is a fully-owned subsidiary of Cadista Holdings Inc, which is a part of the Noida-based Jubilant Life Sciences Company.
As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), the Salisbury-based Jubilant Cadista is recalling the drug for "failed dissolution specifications". The voluntary recall initiated by the company includes 3,072 bottles of 30 count and 2,688 bottles of 90 count.
The medicine was manufactured at Jubilant's Roorkee plant. The USFDA said the product was distributed to one customer who may have further distributed the product.
A mail sent to the company to obtain comments remained unanswered. In October 2018, Jubilant Cadista Pharmaceuticals had recalled over 1.58 lakh bottles of Pantoprazole Sodium delayed-release tablets, manufactured by Jubilant Generics Ltd at its Roorkee plant, from the America and Puerto Rico market.
In September 2018, the company had recalled over 46,000 bottles of Valsartan tablets manufactured at the same plant.
(With inputs from agencies.)
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