<div> Three different drugs made in India, including by Cadila Pharma and Alkem Laboratories, are being recalled in the US for not meeting the manufacturing norms.<br /><br />According to the latest Enforcement Report of the USFDA, Cadila Pharmaceuticals Ltd is recalling 6 kg of Ondansetron HCI API manufactured by the company on account of microbial contamination of non-sterile product. The voluntary ongoing recall is a class II recall, it added.<br /><br />"According to the firm, the API was distributed to two consignees in the US," the United States Food and Drug Administration (USFDA) said.<br /><br />In another case, Par Pharmaceutical Inc is recalling a total of 242,304 bottles of Travoprost ophthalmic solution USP in the strength of 0.004 per cent in 2.5 mL and 5 mL bottles, that were made in India.<br /><br />The reason for the recall is "lack of assurance of sterility; damage to the internal portion of the dropper tip portion of the container," the USFDA said, adding the nationwide voluntary recall was a class II recall, as per the Enforcement Report.<br /><br />Likewise, 1,739 bottles of Metformin Hydrochloride Tablets, USP 500 mg, manufactured by Mumbai based Alkem Laboratories are being recalled by distributing firm Ascend Laboratories LLC.<br /><br />"Reason for recall is presence of foreign tablets/ capsules; report of Amlodipine tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP," the Enforcement Report said.<br /><br />This is also a class II recall, USFDA said. As per the USFDA, a class II recall is initiated in a "situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".</div>
<div> Three different drugs made in India, including by Cadila Pharma and Alkem Laboratories, are being recalled in the US for not meeting the manufacturing norms.<br /><br />According to the latest Enforcement Report of the USFDA, Cadila Pharmaceuticals Ltd is recalling 6 kg of Ondansetron HCI API manufactured by the company on account of microbial contamination of non-sterile product. The voluntary ongoing recall is a class II recall, it added.<br /><br />"According to the firm, the API was distributed to two consignees in the US," the United States Food and Drug Administration (USFDA) said.<br /><br />In another case, Par Pharmaceutical Inc is recalling a total of 242,304 bottles of Travoprost ophthalmic solution USP in the strength of 0.004 per cent in 2.5 mL and 5 mL bottles, that were made in India.<br /><br />The reason for the recall is "lack of assurance of sterility; damage to the internal portion of the dropper tip portion of the container," the USFDA said, adding the nationwide voluntary recall was a class II recall, as per the Enforcement Report.<br /><br />Likewise, 1,739 bottles of Metformin Hydrochloride Tablets, USP 500 mg, manufactured by Mumbai based Alkem Laboratories are being recalled by distributing firm Ascend Laboratories LLC.<br /><br />"Reason for recall is presence of foreign tablets/ capsules; report of Amlodipine tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP," the Enforcement Report said.<br /><br />This is also a class II recall, USFDA said. As per the USFDA, a class II recall is initiated in a "situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".</div>