According to a USFDA notice, Macleods Pharmaceuticals is recalling two medications in the US market owing to deviations from established production criteria.
The US Food and Drug Administration (USFDA) has issued a recall for 3,672 bottles of Amlodipine and Olmesartan Medoxomil tablets, which are used to treat high blood pressure.
According to the US Food and Drug Administration, Macleods Pharma USA Inc, located in New Jersey, is recalling the concerned batch owing to the good manufacturing principleseCGMP violations.
Macleods Pharmaceuticals, located in Mumbai, produced the lot in its Baddi (Himachal Pradesh) manufacturing facility.
On February 15, this year, the business issued a countrywide Class II recall.
In the United States, Macleods is recalling a large number of Olanzapine pills, which are used to treat schizophrenia.
The business is also recalling the concerned lot due to eCGMP violations, according to the USFDA.
The afflicted batch was manufactured at the company’s Baddi factory and afterwards marketed in the United States by Macleods Pharma USA Inc.
According to the USFDA, a Class II recall is launched when the use or exposure to a violative product may produce transitory or medically reversible adverse health effects, or when the risk of major adverse health effects is low.
The generic medication market in the United States was anticipated to be worth roughly USD 115.2 billion in 2019, according to industry estimates.
Macleods Pharmaceuticals was founded in 1989 and now has eight production facilities in India. It manufactures oral solids, oral liquids, granules, dry syrups, inhalers and aerosols, topicals, and injectables in a variety of dosage forms (tablets and capsules, including soft gelatin capsules).
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