Macleods Pharmaceuticals is recalling two products in the US market due to deviation from standard manufacturing norms, according to a USFDA report.
According to the latest enforcement report issued by the US Food and Drug Administration (USFDA), the US-based arm of the drug firm is recalling 3,672 bottles of Amlodipine and Olmesartan Medoxomil tablets, used to treat high blood pressure.
According to the US health regulator, the New Jersey-based Macleods Pharma USA is recalling the affected lot due to "eCGMP (current good manufacturing practices) deviations".
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The lot has been manufactured by the Mumbai-based Macleods Pharmaceuticals at its Baddi (Himachal Pradesh) based production plant.
The company initiated the nationwide Class II recall on February 15 this year.
Macleods is also recalling a lot of Olanzapine tablets, used to treat schizophrenia, in the US market. The USFDA noted that the company is recalling the affected lot also for eCGMP deviations.
The company had produced the affected lot at its Baddi plant and later marketed in the US market by Macleods Pharma USA Inc.
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The company initiated the Class II voluntary recall on February 16, 2022.
As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
According to industry estimates, the US generic drug market was estimated to be around USD 115.2 billion in 2019.
Established in 1989, Macleods Pharmaceuticals has eight manufacturing units in India. It produces a wide range of formulations in multiple 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 across various countries including the US, the UK and Spain.
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