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  • Sun Pharma, Dr Reddy's...

Sun Pharma, Dr Reddy's Labs recall products in US over manufacturing issues

Ruchika SharmaWritten by Ruchika Sharma Published On 2022-12-05T13:30:57+05:30  |  Updated On 5 Dec 2022 6:54 PM IST
Sun Pharma, Dr Reddys Labs recall products in US over manufacturing issues
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The health regulator further said the US-based arm of Sun Pharma is recalling 14,064 cartons of a medication to treat erosive esophagitis or heartburn caused by gastroesophageal reflux disease (GERD).

New Delhi: Drug majors Dr Reddy's Laboratories and Sun Pharma are recalling different products in the US market for manufacturing issues, according to the US Food and Drug Administration.

As per the enforcement report by the US health regulator, the US-based arm of Dr Reddy's Laboratories is recalling over 48,000 cartons of a drug used to treat sneezing, runny or stuffy nose. It is recalling 25,176 cartons of 30-count tablets and 22,968 cartons of 20-count tablets.

According to USFDA, Dr Reddy's Laboratories is recalling the affected lot due to "failed stability specifications".
New Jersey-based Dr Reddy's Laboratories, Inc initiated the Class III recall on November 21 this year. As per USFDA, 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".
Read also: Aurobindo Pharma units recall products in US over manufacturing lapses
The health regulator further said the US-based arm of Sun Pharma is recalling 14,064 cartons of a medication to treat erosive esophagitis or heartburn caused by gastroesophageal reflux disease (GERD). The company is recalling the affected lot, produced at its Mohali plant, due to "discoloration", it added.
Read also: Sun Pharma gets CDSCO panel nod to manufacture, market Esomeprazole dual release gastroresistant tablets
Sun Pharmaceutical Industries Inc commenced the Class II voluntary recall in the US on July 25 this year. 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.
According to industry estimates, the US generic drug market was estimated at around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.

Read also: Dr Reddys beats Aurobindo Pharma to become second biggest drug maker in India: Report

sun pharmaUSFDAsneezingerosive esophagitisheartburngastroesophageal reflux diseaseDr Reddys labsdr reddys labs newsrecall
Source : PTI
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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