The US-based arm of the drug agency is recalling the affected lot of 500 mg tablets (in 500 depend bottles) resulting from “presence of international substance recognized as activated carbon”, as per the most recent Enforcement Report issued by the US well being regulator.
The tablets have been produced at drug main’s Halol (Gujarat) primarily based manufacturing plant and later distributed within the US by Cranbury (NJ) primarily based Sun Pharmaceutical Industries, Inc. The USFDA has categorized the voluntary recall undertaken by the drugmaker as class II recall.
As per the USFDA, a category II recall is initiated in a state of affairs through which use of, or publicity to, a violative product could trigger short-term or medically reversible adversarial well being penalties or the place the likelihood of great adversarial well being penalties is distant.
Solar Pharmaceutical Industries has initiated the nationwide recall on Could 4 this 12 months. Shares of the drug main ended 0.52 % up at Rs 690.35 apiece on the BSE on Friday.