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 Clonidine 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”, US FDA noted.
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.”
Similarly, the US-based arm of Lupin is voluntarily recalling 4,224 bottles of a product in the country.
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.
Lisinopril tablets are used to treat high blood pressure.
The product has been manufactured at Mumbai-based Lupin’s Nagpur plant.
As per 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.”