BREAKING NEWS: Macleods Pharmaceuticals Issues Class II Recall Of Its Products - medtigo


BREAKING NEWS: Macleods Pharmaceuticals Issues Class II Recall Of Its Products

Share on facebook
Share on twitter
Share on linkedin
Share on whatsapp

According to a USFDA notice and as reported by Business Standard, Macleods Pharmaceuticals recalls two medications in the US market due to deviations from established manufacturing 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, based in New Jersey, recalls the concerned batch due to “cGMP (current good manufacturing principles) violations.”

Macleods Pharmaceuticals, located in Mumbai, produced the lot in its Baddi (Himachal Pradesh) manufacturing facility.

On February 15, the business issued a countrywide Class II recall.

In the United States, Macleods recalls many Olanzapine tablets used to treat schizophrenia. The company is also reflecting the concerned lot due to cGMP violations, according to the USFDA.

The afflicted batch was manufactured at the company’s Baddi factory and afterward marketed in the United States by Macleods Pharma USA Inc.

On February 16, 2022, the business issued a Class II voluntary recall.

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 significant adverse health effects is low.

According to industry estimates, the generic medication market in the United States was anticipated to be worth roughly USD 115.2 billion in 2019.

Macleods Pharmaceuticals was founded in 1989 and now has eight production facilities in India. It manufactures oral solids (tablets and capsules, including soft gelatin capsules), oral liquids, dry syrups, topicals, granules, inhalers and aerosols, and injectables in various dosage forms.

The company operates in several countries, including the United States, the United Kingdom, and Spain.

Leave a Reply