Macleods Pharmaceuticals is recalling two products in the US market due to deviation from standard manufacturing norms, according to a US Food and Drug Administration (FDA) report. According to the latest enforcement report issued by the FDA, 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.
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 15th February this year.
Macleods is also recalling a lot of Olanzapine tablets, used to treat schizophrenia, in the US market. The FDA 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.