associate sponsors


Lupin, Dr Reddy's recall 1.7 lakh blood pressure, acidity tablets in US

New Delhi: 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 & Hydrochlorothiazid 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.

Updated Date: Jul 07, 2016 10:59 AM

Also Watch

Social Media Star: Abhishek Bachchan, Varun Grover reveal how they handle selfies, trolls and broccoli
  • Monday, July 16, 2018 It's a Wrap: Soorma star Diljit Dosanjh and Hockey legend Sandeep Singh in conversation with Parul Sharma
  • Monday, July 16, 2018 Watch: Dalit man in Uttar Pradesh defies decades of prejudice by taking out baraat in Thakur-dominated Nizampur village
  • Monday, July 16, 2018 India's water crisis: After govt apathy, Odisha farmer carves out 3-km canal from hills to tackle scarcity in village
  • Sunday, July 15, 2018 Maurizio Sarri, named as new Chelsea manager, is owner Roman Abramovich's latest gamble in quest for 'perfect football'