usfda: Macleods Pharmaceuticals recalls products in US over manufacturing issues

Macleods Pharmaceuticals is recalling two products from the US market due to a deviation from standard manufacturing standards, according to a USFDA report. According to the latest enforcement report released by the United States Food and Drug Administration (USFDA), the pharmaceutical company’s US branch is recalling 3,672 bottles of amlodipine and olmesartan medoxomil tablets, used to treat hypertension arterial.

According to US health regulator, New Jersey-based Macleods Pharma USA is recalling the affected lot due to “eCGMP (current good manufacturing practice) deviations”.

The batch was manufactured by Mumbai-based Macleods Pharmaceuticals at its production facility based in Baddi (Himachal Pradesh).

The company launched the nationwide Class II recall on February 15 this year.

Macleods is also recalling a large number of Olanzapine tablets, used to treat schizophrenia, from the US market. The USFDA noted that the company is also recalling the affected lot for eCGMP discrepancies.

The company had produced the affected batch at its Baddi plant and then commercialized in the US market by Macleods Pharma USA Inc.

The company initiated the Class II voluntary recall on February 16, 2022.

According to the USFDA, a Class II recall is initiated in a situation where use of or exposure to an offending product may result in temporary or medically reversible adverse health consequences or when the likelihood of serious adverse health consequences health is low.

According to industry estimates, the US generic drug market was estimated at around $115.2 billion in 2019.

Founded in 1989, Macleods Pharmaceuticals has eight manufacturing units in India. It produces a wide range of formulations in several dosage forms, including oral solids (tablets and capsules, including soft gelatin capsules), oral liquids, dry syrups, topicals, granules, inhalers and aerosols. , and injectables.

The company has a presence in various countries, including the United States, United Kingdom and Spain.

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