Sun Pharma, Lupin recall products in US market


PTI, Jan 16, 2022, 11:05 AM IST

Leading drug makers Sun Pharma and Lupin are recalling products in the US, the world’s largest market for medicines, for different reasons. As per the latest enforcement report by the US Food and Drug Administration (USFDA), Sun Pharma is recalling 696 bottles of Pregabalin capsules (50 mg), used for the treatment of epilepsy, anxiety, and nerve pain, in the US market. According to the US health regulator, the Mumbai-based drug major is recalling the affected lot due to ”failed tablet/capsule specifications: out of specification results for particle size distribution and bulk density of the active pharmaceutical ingredient”. New Jersey-based Sun Pharmaceutical Industries Inc, a unit of the company, initiated Class II nationwide (US) recall of the affected lot on October 22 last year. As per the 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. Lupin, on the other hand, is recalling 50,832 bottles of Gatifloxacin Ophthalmic Solution, an antibiotic used to treat bacterial infections of the eyes. As per the USFDA, the company’s US-based unit is recalling the affected lot due to ”failed stability specifications: out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.” The affected lot has been manufactured at Lupin’s Pithampur-based plant in Madhya Pradesh. The lot has been distributed in the US by Baltimore-based Lupin Pharmaceuticals Inc, the report stated. The drug maker initiated Class III voluntary recall in the US and Puerto Rico on December 22 last year. Lupin is also recalling 23,965 bottles of Oxycodone Hydrochloride tablets, used for the treatment of moderate to severe pain. As per the USFDA, the company is recalling the lot due to ”out-of-specification impurity test result observed at 18-month long term stability time point.” The company’s US-based subsidiary initiated Class III recall on December 29 last year. A Class III recall is initiated in a ”situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.” The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.

Udayavani is now on Telegram. Click here to join our channel and stay updated with the latest news.

Top News

Deputy CM Shivakumar hints about Cabinet reshuffle on cards in Karnataka

BJP to corner Congress govt in K’taka on Waqf issue, alleged scams, during legislature session

Section 52A of Waqf Act has no retrospective effect, says Kerala HC

Seeding car crashes into divider on highway in Mumbai; Two college students dead

NADA suspends Bajrang Punia for four years for violation of anti-doping code

Alphabet gets CCI’s clearance to acquire stake in Flipkart

‘COVID was different’: SC bemoans distribution of free ration

Related Articles More

Alphabet gets CCI’s clearance to acquire stake in Flipkart

Essar Group co-founder Shashi Ruia dies at 80

Sensex, Nifty climb in early trade amid fresh foreign fund inflows

RBI Governor Shaktikanta Das hospitalised

Sensex reclaims 80k mark; Nifty surges over 1% after BJP-led Mahayuti’s win in Maharashtra

MUST WATCH

Grafting

Coconut Flower

Prakash Belawadi

Naxal Leader Vikram Gowda

Christmas Cake Fruit Mixing


Latest Additions

Geethartha Chinthane 106: Prioritize relieving grief, not amplifying it

Law should be brought in where Muslims don’t have voting power, says seer during Waqf protest

Moodbidri: Former physical education director P. Nemiraj Hegde passes away

Railways Minister responded positively to Konkan Railway merger proposal: Kota Srinivas Poojary

Deputy CM Shivakumar hints about Cabinet reshuffle on cards in Karnataka

Thanks for visiting Udayavani

You seem to have an Ad Blocker on.
To continue reading, please turn it off or whitelist Udayavani.