Lupin, Unichem recall BP drugs in US over quality issue
The Class-II recall is on account of "Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle," the report said.;
New Delhi: Pharma companies Unichem Laboratories and Lupin are separately recalling certain batches of drugs from the US market due to quality issues.
As per the latest enforcement report issued by the US Food and Drug Administration (USFDA), Unichem is voluntarily recalling 1,90,992 bottles of Clonodine Hydrochloride tablets, which are used to treat high blood pressure.
Unichem Pharmaceuticals (USA), the US-based arm of the company, is recalling the drug for "failed impurities/ degradation specifications".
There can be "potential migration of benzophenone at very low level into the product from container", the US health regulator noted in the report.
The specified batch, which is being recalled, has been manufactured at Unichem's Goa-based facility.
The USFDA has classified the action as a Class-III recall, which is initiated in a situation "in which use of or exposure to a violative product is not likely to cause adverse health consequences."
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