Sun Pharma initiates recall of Febuxostat for gout in US
2024-03-11
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来源: Pharmaceutical Technology
The US Food and Drug Administration has classified the development as a Class II recall. Credit: sumroeng chinnapan / Shutterstock.com.
Sun Pharmaceutical Industries has announced a recall of 55,000 bottles of Febuxostat, a medication used to treat gout, from the US market, PTI has reported.
The recall is due to deviations from current good manufacturing practice (CGMP) regulations.
The US Food and Drug Administration (FDA) has classified the development as a Class II recall, meaning that exposure to the affected product may lead to temporary or medically reversible adverse health consequences.
The recall encompasses 47,520 bottles of 40mg strength and 7,488 bottles of 80mg strength Febuxostat tablets.
The FDA reported microbial contamination in stagnant water in the duct of the manufacturing equipment.
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The affected lot was manufactured at Sun Pharma’s Dadra, India plant and was intended for Northstar Rx, based in Memphis.
The recall began on 4 March 2024 and has been classified as nationwide in the US.
Sun Pharma is a generic pharmaceutical sector giant in the US.
The US generic drug market was valued at $115.2bn in 2019.
The development comes after Sun Pharma signed a definitive merger agreement in January 2024 to acquire all outstanding ordinary shares of Taro Pharmaceutical not currently owned by the company or its affiliates for $347.73m (Rs28.92bn) in cash.
In an intimation letter published on 12 December 2023, Sun Pharma expressed interest in a takeover of Taro.
Taro develops off-patent pharmaceuticals and supplies prescription and over-the-counter products such as tablets, capsules and topical formulations to markets including Canada, Israel and the US.
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