US subsidiaries of Indian pharmaceutical companies Aurobindo Pharma and Zydus Lifesciences recalled various products from the US market according to the US Food and Drug Administration.
Zydus recalled 7,248 bottles of Oxybutynin Chloride Extended-Release Tablets. The recall was initiated on 21 September 2023 voluntarily by the company, according to the daily U.S. Food and Drug Administration (US FDA) Recall Information updates. Medicines in the 100g and 500g specifications were recalled nationwide in the US.
US FDA stated that the reason for this recall was “Failed Dissolution Specifications”, according to US FDA. Oxybutynin Chloride Extended-Release Tablets are used to treat overactive bladder and urinary conditions.
The product was manufactured at Cadila Healthcare Ltd., Ahmedabad, and distributed by a wholly owned subsidiary of Zydus Lifesciences, Zydus Pharmaceuticals (USA) Inc.
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Aurobindo Pharma recalled 1,626 vials of Triamcinolone Acetonide Injectable Suspension. The product was recalled by Eugia US LLC, a 100 percent owned subsidiary of Aurobindo Pharma Ltd.
The recall was initiated on 28 September according to the daily U.S. Food and Drug Administration Recall Information updates. The product will be recalled voluntarily by the company nationwide in the US. The medicine is used to treat inflammation (swelling), allergic reactions, certain types of arthritis and skin diseases.
The product was manufactured in India according to the US FDA notification. The product was recalled because “a piece of glass was identified in a vial,” according to US FDA.
Both the recalls were classified as a class II recall by the US FDA. According to the US FDA, a class II recall happens in “a situation in which use of or exposure to a volatile product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”.
Also copy: Aurobindo Pharma falls 2.5% after USFDA observation on Telangana unit
Both the companies did not respond to email enquiries on the matter.
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