Indian drug manufacturers The US Food and Drug Administration (USFDA) has announced that Aurobindo Pharma, Glenmark, and FDC are recalling products in the US because of manufacturing defects. The painkiller Healthy Living Acetaminophen, Aspirin (NSAID), and Caffeine tablets are being recalled from 240 bottles by Aurobindo Pharma USA Inc., a division of the Hyderabad-based pharmaceutical company Aurobindo Pharma USA Inc.
As to the most recent enforcement report from the USFDA, the corporation is recalling the impacted lot because of a “Missing Label.”
According to the US health agency, the manufacturer’s label including the drug facts information is missing from some bottles.
According to Aurobindo Pharma USA Inc., a company based in New Jersey, the Class 1 recall was started on July 11.
A Class I recall, according to the US health authorities, concerns faulty items that have the potential to seriously harm consumers’ health.
Similar to this, the USFDA announced that 2,404 bottles of Indomethacin Extended-Release Capsules made in a Madhya Pradesh factory are being recalled by a Glenmark Pharmaceuticals subsidiary located in the US owing to “Failed Dissolution Specifications”.
The Class II recall was started on July 31 by Glenmark Pharmaceuticals Inc., USA, it continued.
According to a USFDA report, Timolol Maleate Ophthalmic Solution USP bottles numbering 1,76,784 are being recalled by Maharashtra-based medication manufacturer FDC Ltd because of a “Defective Container”.
According to the statement, patients are unable to remove the solution from the bottle because the cap’s spike is stuck in the product container’s nozzle.
August 12 of this year marked the start of the Class II recall by the corporation.
According to the USFDA, a Class II recall is started when there is little chance of major adverse health effects from using or being exposed to a violative product, or when there may be transient or medically recoverable adverse health effects.
The largest concentration of non-US FDA-compliant pharmaceutical factories is found in India.
