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.
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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.