Last Updated on December 31, 2023 by The Health Master
Macleods Pharmaceuticals is recalling two products in the U.S. market for deviations from standard manufacturing practices.
According to the latest enforcement report from the U.S. Food and Drug Administration (USFDA), the U.S.-based division of the pharmaceutical company has recalled the following:
3,672 amlodipine and olmesartan medoxomil tablets are used to treat high blood pressure.
New Jersey-based Macleods Pharma USA Inc is recalling affected batches due to “eCGMP (current Good Manufacturing Practice) discrepancies,” according to U.S. health officials.
According to the USFDA, a Class II recall is a situation in which use or exposure to an infringing product may cause temporary or medically reversible adverse health effects, or situations in which serious adverse health effects are unlikely.
The batch was manufactured by his Mumbai-based Macleods Pharmaceuticals at its manufacturing facility in Badi, HP.
On February 15, 2015, the company started a second-class recall on a nationwide scale. Macleods is also recalling a number of olanzapine tablets used to treat schizophrenia in the US market.
The USFDA noted that it is also recalling affected batches due to eCGMP discrepancies.
The company manufactured the affected batch at its Buddy facility and later commercialized it in the U.S. market by McLeods Pharma USA Inc. The company initiated a Type 2 voluntary recall on February 16, 2022.
The company manufactures a wide range of formulations in multiple dosage forms, including oral solids (tablets and capsules, including soft gelatin capsules), oral liquids, dry syrups, topical agents, granules, inhalers and aerosols, and injectables. doing. The company has a presence in different countries, such as the USA, the UK, and Spain.
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