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. 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.
“According to the firm, the API was distributed to two consignees in the US,” the United States Food and Drug Administration (USFDA) said.
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.
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.
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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.
“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.
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”.