Hyderabad-based Aurobindo Pharma recalls over 4,000 bottles of pain relieving drug

US-based unit of the drug major is recalling Acetaminophen Tablets (325 mg) in the US due to cGMP (Current Good Manufacturing Practices) deviations

New Delhi: Aurobindo Pharma is recalling over 4,600 bottles of a pain relieving drug in the US market due to manufacturing issues, according to the US health regulator.

A US-based unit of the Hyderabad-based drug major is recalling 4,608 bottles of Acetaminophen Tablets (325 mg) in the US due to cGMP (Current Good Manufacturing Practices) deviations, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report.

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The affected lot is being recalled “due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets)”, it added. The medication is used to relieve headaches, migraine, toothache, back pain and muscle pain, among others.

Princeton-based Aurobindo Pharma USA Inc initiated the Class II recall on May 22 this year. As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.

Shares of Aurobindo Pharma on Friday were trading 0.08 per cent up at Rs 1,124.05 apiece on BSE.