New Delhi:
US-based Jubilant Cadista Pharmaceuticals is recalling 4,416 bottles of clomipramine Hydrochloride capsules, an antidepressant used to treat various conditions including obsessive compulsive disorder, in the American 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 tablet/capsule specification”. The voluntary Class II recall initiated by the company on November 6 includes 50 mg clomipramine Hydrochloride capsules in 30-count bottles.
As per the USFDA, a class II recall is initiated in a situation in which 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. In March last year, the company had announced a recall of over 5,700 bottles of Bupropion Hydrochloride extended-release tablets, used to treat major depressive disorder, from the US market.
In October 2018, Jubilant Cadista 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.
