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Safety first: Aurobindo recalls discolored pain relieving drug in US

U.S.: In a swift move to protect consumers, Aurobindo Pharma‘s U.S. unit is recalling more than 4,600 bottles of its pain reliever, Acetaminophen Tablets (325 mg), in the US market due to manufacturing issues.

As per the latest Enforcement Report of the US Food and Drug Administration (USFDA), the US unit is recalling 4,608 bottles of the said drug due to cGMP (Current Good Manufacturing Practices) deviations.

The medication is used to relieve headaches, migraine, toothache, back pain and muscle pain, among others.

The affected lot is being recalled “due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets)”, PTI reported.

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.
Last year, Aurobindo Pharma USA recalled over 1 lakh bottles of Cinacalcet tablets in multiple strengths due to “GMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit.

Aurobindo Pharma Limited, is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 30+ manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s product portfolio is spread over seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and AntiAllergic, supported by a strong R&D set-up.

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