Drug majors Lupin and Dr Reddy’s are recalling over 1.7 lakh bottles of two different tablets, used in the treatment of blood pressure and acidity, in the US due to deviations from manufacturing norms.
According to the latest Enforcement Report of United States Food and Drug Administration (USFDA) Lupin’s US arm – Lupin Pharmaceuticals Inc – is recalling 59,520 bottles of Lisinopril & Hydrochlorothiazide tablets USP 20mg/12.5mg, 5,880 bottles of Lisinopril tablets, USP 40 mg and 20,587 bottles of Lisinopril tablets, USP 30mg due to deviation from current good manufacturing practice (CGMP).
The “finished products (were) manufactured using active pharmaceutical ingredients whose intermediates failed specifications,” the report said, adding the ongoing nation-wide recall is also being carried out in Puerto Rico.
As per the report, the recall is 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.”
The drugs are manufactured at the company’s Pithampur plant in Madhya Pradesh.
In case of Dr Reddy’s Laboratories, its US arm Dr Reddy’s Laboratories Inc, is recalling 84,240 bottles of Famotidine 10 mg tablets.
On the reason of the recall, the report mentioned that “an out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the tablet”.
It is an class III recall, the Enforcement Report said.
Date: 7th July, 2016