Macleods Pharma recalls 10,000 bottles of antibacterial drugs in the US for mislabeling

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Due to a labeling problem, Macleods Pharmaceuticals is recalling 10,052 bottles of levofloxacin tablets from the US market, according to US health authorities. Macleods Pharma Inc., a US-based division of the company, is recalling these drugs according to the most recent compliance report from the US Food and Drug Administration (USFDA).

Levofloxacin tablets are used to treat various bacterial infections.

Due to the “mismatch of the embossing of the tablets with the embossing specified in the package insert of the distributed bottles”, the company is recalling the affected batch.

The damaged batch was produced by Macleods at its Baddi-based manufacturing facility in Himachal Pradesh.

On January 5, the company initiated the Class III recall in the US and Puerto Rico.

According to the USFDA, a Class III recall is initiated in a “situation where use of or exposure to an infringing product is unlikely to cause adverse health consequences.”

In 2019, the US generic drug market was forecast to be worth about $115.2 billion. It is, without a doubt, the world’s largest market for pharmaceuticals.

India’s pharmaceutical exports exceeded US$24.62 billion in the most recent fiscal year, with the US, UK, South Africa, Russia and Nigeria emerging as the top five markets.

The Mumbai-based company is active in several therapeutic areas, including dermatological, cardiovascular, antidiabetic and hormonal therapy.

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