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Macleods Pharma recalls 10000 bottles of anti bacterial medication in US over labelling error

By - Ruchika Sharma
Published On 2023-01-27 06:00 GMT   |   Update On 2023-01-27 07:35 GMT

New Delhi: Macleods Pharmaceuticals is recalling around 10,000 bottles of generic antibiotic medication in the US market due to a labelling error, according to the US health regulator. As per the latest enforcement report by the US Food and Drug Administration (USFDA), Macleods Pharma Inc, a US-based unit of the company, is recalling 10,052 bottles of Levofloxacin tablets, which are used to...

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New Delhi: Macleods Pharmaceuticals is recalling around 10,000 bottles of generic antibiotic medication in the US market due to a labelling error, according to the US health regulator. As per the latest enforcement report by the US Food and Drug Administration (USFDA), Macleods Pharma Inc, a US-based unit of the company, is recalling 10,052 bottles of Levofloxacin tablets, which are used to treat different types of bacterial infections.

The company is recalling the affected lot due to "mismatching of the embossing on the tablets with the embossing mentioned in the package insert in the distributed bottles."
Macleods manufactured the affected lot in its Baddi-based manufacturing plant in Himachal Pradesh. The company initiated the Class III recall in the US and Puerto Rico on January 5.
As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences."
The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is by far the largest market for pharmaceutical products in the world.
In the last financial year, India's pharma exports stood at around USD 24.62 billion with the US, the UK, South Africa, Russia, and Nigeria emerging as the top five destinations.
Established in 1989, Macleods Pharmaceuticals is engaged in developing, manufacturing, and marketing a wide range of formulations across several major therapeutic areas including anti-infectives, cardiovascular, anti-diabetic, dermatology, and hormone treatment.

Read also: Macleod Pharma gets CDSCO panel conditional nod to study FDC Sitagliptin, Metformin, Glimepiride

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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